Siemens Healthcare Diagnostics, Inc. recalls
Every recall we track for Siemens Healthcare Diagnostics, Inc. — 344 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Siemens Healthcare Diagnostics, Inc. peaked in 2018 (77); 344 since 2017.
All FDA recall records for Siemens Healthcare Diagnostics, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 22 | 1 | 24 |
| 2018 | 0 | 8 | 69 | 0 | 77 |
| 2019 | 0 | 0 | 26 | 0 | 26 |
| 2020 | 0 | 3 | 40 | 0 | 43 |
| 2021 | 0 | 0 | 43 | 0 | 43 |
| 2022 | 0 | 0 | 35 | 0 | 35 |
| 2023 | 0 | 6 | 26 | 1 | 33 |
| 2024 | 0 | 7 | 25 | 1 | 33 |
| 2025 | 0 | 2 | 16 | 0 | 18 |
| 2026 (to date) | 0 | 2 | 10 | 0 | 12 |
Most common reasons for Siemens Healthcare Diagnostics, Inc. recalls
What to do if you have a recalled Siemens Healthcare Diagnostics, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Siemens Healthcare Diagnostics, Inc. recalls
60 shown- Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Siemens Healthcare recalls Atellica CH Revised C-Reactive Protein tests with potential for falsely elevated results. All units are affected. Contact for remedy.
Siemens HealthcareAug 17, 2026 - Use cautionMedical device
Siemens Healthcare Diagnostics, Inc. recalls Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Beckman Coulter recalls Emit 2000 Quinidine Assay kits with specific lot numbers due to potential for inaccurate quinidine measurements, risking suboptimal patient treatment and possible life-threatening cardiac issues.
Beckman CoulterJul 13, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Siemens Healthcare recalls Atellica CH Urine Albumin REF: 11537225 due to potential false low results for urea nitrogen and hemoglobin A1c tests, affecting diagnostic accuracy.
Siemens HealthcareJul 6, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Siemens Healthcare recalls Syva Emit Disopyramide Assay kits with potential low sodium azide risk. Lab technicians may experience mild skin or eye irritation but serious injury is unlikely.
Siemens HealthcareJun 26, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Siemens Healthcare recalls Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls with low sodium azide risk. Lab technicians may experience mild skin or eye irritation from small volumes.
Siemens HealthcareJun 26, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Siemens recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E) devices due to potential for false low or high blood sugar results. Affected units may need recalibration or replacement.
Siemens HealthcareJun 8, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Siemens recalls Dimension Tacrolimus Flex reagent cartridges (lots FA6254, FA6260, FA6286) due to possible positive bias in quality control and patient test results. Affected units may show inaccurate results.
Siemens HealthcareMay 7, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Siemens Healthcare recalls epoc BGEM BUN Test Cards (25 pack) for inaccurate pH and CO2 results, which could lead to incorrect treatment of acidosis or alkalosis. Affected units have specific lot numbers and material numbers.
Siemens HealthcareApr 2, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare recalls Dimension Creatinine Flex reagent cartridges with lot numbers GA6307 and BA7005 due to potential inaccuracies in creatinine patient results. Affected units may show erroneously low or high creatinine levels.
Siemens HealthcareMar 18, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Siemens recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E) test kits that may produce lower than actual results when used with certain analyzers, potentially delaying diabetes diagnosis.
Siemens HealthcareFeb 23, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Siemens Healthcare recalls Atellica CH Urine Albumin (UAlb) with material number 11537225 due to potential false low results in urine albumin tests. All units are affected.
Siemens HealthcareJan 20, 2026 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Siemens Healthcare recalls Food Panel 3 Specific Allergen (SMN 10385891) due to barcode scanning errors with IMMULITE 2000 instruments. Affected units may not correctly read tube positions in allergen holders when used with Zebra scanners.
Siemens HealthcareOct 6, 2025 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog
Siemens Healthcare recalls specific lots of IMMULITE 2000 Intact PTH tests that may produce falsely low PTH results, affecting patient diagnosis. Check your test lot numbers to see if affected.
Siemens HealthcareSep 22, 2025 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Siemens Healthcare recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) tests with material number 11097543 due to potential false low results in patient testing.
Siemens HealthcareAug 11, 2025 - Lower riskMedical device
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Siemens Healthcare recalls Epoc BGEM BUN Test Cards with potential sodium bias. Affected lots may show inaccurate sodium readings. No remedy specified in official notice.
Siemens HealthcareJul 7, 2025 - Use cautionMedical device
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Siemens Healthcare recalls RAPIDPoint 500 Wash/Waste Cartridges (Lot WW/08925) due to potential patient treatment delays from inaccurate lab results. Affected units may cause errors in calcium, potassium, and other critical tests.
Siemens HealthcareJun 26, 2025 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Siemens Healthcare recalls ADVIA 120/2120/2120i 3-in-1 TESTpoint Control units with incorrect platelet value assignments. Affected units may provide inaccurate blood test results.
Siemens HealthcareJun 4, 2025 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Siemens Healthcare recalls Atellica CH Diluent (SMN 11099300) due to sodium hypochlorite contamination that may affect lab test results. Affected units include specific lot numbers and sizes.
Siemens HealthcareMay 22, 2025 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Siemens recalls Atellica IM Homocysteine Calibrator (2 Pack) due to unstable calibrators causing inaccurate test results. Affected lots may give false high readings. Contact Siemens for details.
Siemens HealthcareApr 15, 2025 - Use cautionMedical device
Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Siemens Healthcare recalls Stratus CS Acute Care cTNI TestPak for increased false positive cardiac troponin I results. Affected units have specific lot numbers and serial codes. Stop using immediately to avoid inaccurate heart test results.
Siemens HealthcareMar 31, 2025 - Lower riskMedical device
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc
Siemens recalls epoc BGEM BUN Test Cards (25 pack) with specific software and sensor settings that may cause inaccurate high pH results in blood tests.
Siemens HealthcareMar 19, 2025 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Siemens Healthcare recalls Atellica CH Revised C Reactive Protein (RCRP) tests due to potential for incorrect results. Affected units have Siemens Material Number 11537223 and all lots.
Siemens HealthcareMar 11, 2025 - Use cautionMedical device
Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by
Siemens Healthcare recalls epoc NXS Host software version 4.14.9 due to potential misassignment of patient names in blood tests, risking misdiagnosis. Affected units may need verification steps.
Siemens HealthcareNov 22, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Siemens Healthcare recalls two lots of Magnesium Flex reagent cartridges (K3057) due to potential false low magnesium readings in plasma tests. Affected lots 24057BB and 24064BC may cause incorrect patient results if not detected by quality controls.
Siemens HealthcareNov 12, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CI Analyzer. Catalog Numbers: 10947347.
Siemens Healthcare recalls Atellica CI Analyzer (catalog 10947347) due to potential false elevated sodium, potassium and chloride test results from incorrect diluent volume display.
Siemens HealthcareNov 4, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes
Siemens Healthcare recalls Atellica CH Reaction Ring Cuvette Segments with lot numbers starting with N15 or 15 due to potential imprecision in lab test results for seven analytes.
Siemens HealthcareOct 21, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in
Siemens Healthcare recalls Atellica CH B2M reagents that may produce falsely low results for samples between 18.00-30.00 mg/L, affecting diagnostic accuracy. Affected units include all in-date and future lots with specific material numbers.
Siemens HealthcareOct 21, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Siemens Healthcare recalls IMMULITE 2000 PSA assay kits with specific catalog numbers due to potential high-dose hook effect issues in test results. Affected units may produce inaccurate results; contact for details.
Siemens HealthcareSep 30, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Siemens Healthcare recalls epoc BGEM BUN Test Cards with potential negative sodium bias that could affect blood test accuracy. No injuries reported, but affected lots expired before recall.
Siemens HealthcareSep 24, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Siemens Healthcare recalls Atellica IM aTPO Assay (Material Numbers 10995466 and 10995467) due to potential positive bias in patient results at low levels. Affected lots may show false positives in tests.
Siemens HealthcareAug 21, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in
Siemens Healthcare recalls Atellica CH Microalbumin_2 kits for false low microalbumin readings due to Prozone Effect. Affected units have specific lot numbers and were sold with ADVIA Chemistry systems.
Siemens HealthcareAug 15, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Siemens recalls Dimension Vista TBIL Flex Reagent Cartridges with lot 23206BA due to potential underfilling during manufacturing, which may affect calibrator and patient results.
Siemens HealthcareJul 30, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Siemens Healthcare recalls Atellica CH UCFP reagents with specific lot numbers due to potential for biased quality control and patient results. Affected units may need retesting.
Siemens HealthcareJul 29, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated
Siemens Healthcare recalls Atellica IM CA 19-9 tests that may show falsely high results near the upper limit of normal for some Asian Pacific samples. This could affect cancer screening accuracy.
Siemens HealthcareJul 26, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics Inc recalls Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood
Siemens recalls software version 5.3 for RAPIDPoint 500e Blood Gas Systems. This version incorrectly labels capillary blood samples as arterial in lab systems, risking wrong diagnoses. Affected units include specific models sold in US, China, Japan, and ROW.
Siemens HealthcareMay 17, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
Siemens Healthcare recalls IMMULITE 2000 Anti-TG Ab test kits with specific lots that may cause false elevated thyroid antibody results. Affected kits include catalog # L2KTG2 (200 tests) and lots 782-793.
Siemens HealthcareApr 23, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and
Siemens Healthcare recalls Atellica CH Iron3 analyzers for false high iron results affecting patient tests. Fix by updating software or following specific steps.
Siemens HealthcareMar 13, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls DCA Systems HbA1c Reagent Kit
Siemens Healthcare recalls DCA HbA1c Reagent Kits with potential for incorrect glucose test results due to positive bias. Affected lots may lead to improper diabetes management. Contact for remedy details.
Siemens HealthcareFeb 7, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Erythropoietin (EPO) Assay (100 Test)
Siemens Healthcare recalls Atel:lica EPO Assay kits with negative bias risk. Affected lots may give inaccurate results. Contact for remedy details.
Siemens HealthcareJan 24, 2024 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Siemens Healthcare recalls IgM total test kits that may cause false low results in quality control and patient samples. Affected kits have specific lot numbers and expiration dates.
Siemens HealthcareDec 15, 2023 - Use cautionMedical device
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to
Siemens Healthcare recalls RAPIDPoint 500 Systems Measurement Cartridges with lactate that may cause delayed diagnosis of hypernatremia or hyponatremia, leading to serious health risks. Affected units have specific serial numbers.
Siemens HealthcareOct 26, 2023 - Use cautionMedical device
Siemens Healthcare Diagnostics Inc recalls epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517
Siemens Healthcare recalls epoc NXS Host Blood Analysis System with software versions 4.9.4 to 4.11.11 due to potential erroneous test results, risking misdiagnosis of hyperkalemia or hyperglycemia.
Siemens HealthcareOct 19, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics Inc recalls RAPIDPOINT 500 Blood Gas System
Siemens recalls RAPIDPOINT 500 Blood Gas Systems that may show falsely high sodium levels when used with certain drugs, risking incorrect patient treatment.
Siemens HealthcareSep 26, 2023 - UnratedMedical device
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Siemens Healthcare recalls specific ADVIA Iron_2 reagent kits due to potential false high results in lab tests. Affected kits have material numbers 10377510 and 10341118. No remedy is stated in the recall notice.
Siemens HealthcareAug 8, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the
Siemens Healthcare recalls ADVIA Chemistry UCFP reagent (Material 11319151) that may cause falsely low creatinine results in urine tests. All lots are affected. Contact for replacement.
Siemens HealthcareJul 25, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl
Siemens Healthcare recalls Atellica CH GGT test kits due to possible reagent carryover causing inaccurate results. Affected kits may lead to incorrect patient test outcomes. Contact for remedy details.
Siemens HealthcareJul 10, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Siemens Healthcare recalls specific epoc test cards that may show falsely high glucose levels for samples near the lower end of the reportable range. Affected units include certain software versions and lot numbers with expiry dates through August 2023.
Siemens HealthcareJun 1, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Storage and Retrieval Module (SRM)
Siemens Healthcare recalls Aptio Automation Storage and Retrieval Modules with older software versions due to potential incorrect patient test results from misassociated sample tubes.
Siemens HealthcareMay 16, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic
Siemens Healthcare recalls Atellica CH Toxicology Calibrators due to positive bias in salicylate assays. Affected units have specific Siemens Material Numbers and expiration dates. Consumers should contact Siemens for details.
Siemens HealthcareApr 5, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number
Siemens Healthcare recalls Atellica Cortisol 50T and 250T urine test kits due to potential inaccurate results. Affected kits have specific model numbers and lot ranges. Consumers should contact Siemens for details.
Siemens HealthcareMar 16, 2023 - Use cautionMedical device
Siemens Healthcare Diagnostics, Inc. recalls Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of
Siemens Healthineers recalls Dimension Tacrolimus (TAC) Flex reagent cartridges with lots GA2286, GA3047, and GA3171 due to imprecision causing potential organ failure or toxicity from incorrect tacrolimus dosing.
Siemens HealthineersJan 30, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in
Siemens Healthcare recalls Atel:lica CH Triglycerides reagents that may cause inaccurate magnesium test results due to carryover from other tests.
Siemens HealthcareJan 27, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum
Siemens Healthcare recalls Atellica IM Folate 140 test kits due to negative bias when testing serum samples. Affected kits may give inaccurate folate results. No remedy specified in recall notice.
Siemens HealthcareJan 9, 2023 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative
Siemens Healthcare recalls ADVIA Centaur XP and XPT Anti-HBe2 assays due to potential false positive Hepatitis B e Antigen results. Affected lots may cause inaccurate test outcomes.
Siemens HealthcareDec 22, 2022 - Lower riskMedical device
Siemens Healthcare Diagnostics Inc recalls epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc
Siemens Healthcare recalls Epoc Host 2 devices with specific model numbers due to potential high oxygen recovery during quality control when adjusted for barometric pressure. Affected units include Canada, China, Japan, and refurbished models.
Siemens HealthcareDec 12, 2022 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/
Siemens Healthcare recalls specific IMMULITE 2000 Thyroglobulin kits for potential inaccuracies in thyroid cancer monitoring tests. Users may see inconsistent results with low-level patient samples.
Siemens HealthcareDec 7, 2022 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the
Siemens Healthcare recalls IMMULITE 2000 allergy test kits that may show false mold allergies. These kits use a specific IgE test for allergies in Japan. Affected kits have Siemens Material Number 10711939.
Siemens HealthcareNov 4, 2022 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000
Siemens Healthcare recalls IMMULITE and IMMULITE 1000 testosterone test kits that may show 40% higher results than expected, potentially delaying diagnosis. Affected kits have specific lot numbers and expiration dates.
Siemens HealthcareOct 25, 2022 - Lower riskMedical device
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Siemens recalls Atellica CH 930 Lithium analyzers that may show falsely high lithium levels, risking incorrect treatment. Affected lots: 110354 (exp 11/15/22) and 110038 (exp 2/7/23).
Siemens HealthcareSep 19, 2022 - Lower riskMedical device
SIEMENS HEALTHCARE DIAGNOSTICS INC recalls N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Siemens Healthcare recalls N Antiserum to Human IgG (SMN 10446297) due to potential inaccurate test results. Affected units may not meet expected concentration levels for urine and CSF tests.
Siemens HealthcareAug 30, 2022
Siemens Healthcare Diagnostics, Inc. recall questions
How many recalls has Siemens Healthcare Diagnostics, Inc. had?
344 recalls from Siemens Healthcare Diagnostics, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Siemens Healthcare Diagnostics, Inc. recall?
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;, dated Aug 17, 2026. Every Siemens Healthcare Diagnostics, Inc. recall is listed on this page, newest first.
Why are Siemens Healthcare Diagnostics, Inc. products recalled?
The most common reasons on record: Potential Sample Identification (SID) Mismatch with14-Character Barcodes (20); Homocysteine Assay May Cause Elevated Results in the Folate Assay (3); A steady upward trend in blank (u) absorbance was observed (2); Incorrect calibrator level listed in qualitative calibration steps (2).
What should I do if I have a recalled Siemens Healthcare Diagnostics, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Siemens Healthcare Diagnostics, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.