Every recall we track for Siemens Healthcare Diagnostics, Inc. — 343 in all — plus the complaints and injury reports the public filed about them.
Siemens Healthcare recalls Syva EMIT 2000 Quinidine Assay due to potential inaccurate quinidine measurements, risking suboptimal patient treatment and life-threatening cardiac issues. Affected units include specific lot numbers.
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.
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 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 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 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 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 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 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 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 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 recalls IMMULITE 2000 allergen test devices with specific barcode issues that may cause incorrect tube scanning when used with Zebra scanners. Affected units have SMN 10386105 or catalog L2KUN6. No action needed per recall.
Siemens Healthcare recalls allergy test kits with barcode scanning problems that may cause incorrect tube readings. Affected kits need replacement to ensure accurate allergy test results.
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 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 Healthcare recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) tests with material number 11097543 due to potential false low results in patient testing.
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 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 Healthcare recalls ADVIA 120/2120/2120i SETpoint Calibrators with incorrect platelet value assignments. Affected units have specific Siemens material numbers and lot numbers.
Siemens Healthcare recalls ADVIA 120/2120/2120i 3-in-1 TESTpoint Control units with incorrect platelet value assignments. Affected units have specific material numbers and lot numbers.
Siemens Healthcare recalls ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) due to incorrect platelet value assignments. Affected units have specific material numbers and lot numbers.
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 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 Healthcare recalls ADVIA Centaur HCY Calibrator (2 Pack) with material number 10310376 due to calibration instability causing inaccurate test results. Affected lots include 86237A74, 44207A75, and additional lots listed in the recall notice.
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 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 recalls epoc BGEM Crea Test Cards (25 pack) for potential high pH results with certain software versions. Affected units have specific model numbers and software configurations.
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 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 Healthcare recalls epoc NXS Host software version 4.14.9 due to potential misassignment of patient names in blood tests, risking misdiagnosis and patient safety. Affected units have specific material numbers.
Siemens Healthcare recalls epoc NXS Host blood analysis systems with software version 4.14.9 due to potential misassignment of patient names, risking incorrect diagnoses and treatment. Affected units have specific material numbers and were sold in Europe.
Siemens Healthcare recalls epoc NXS Host software version 4.14.9 due to potential misassignment of patient names in blood tests, risking incorrect diagnoses and treatment. Affected units may need verification steps.
Siemens Healthcare recalls epoc NXS Host devices with software version 4.14.9 due to potential incorrect patient name assignment, risking misdiagnosis and patient safety.
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 to prevent errors.
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 have Siemens Material Number 11413518.
Siemens Healthcare recalls epoc NXS Host software version 4.14.9 due to potential misassignment of patient names in blood tests, risking incorrect diagnoses. Affected units may need verification of patient identity before testing.
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 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 Healthcare recalls Atellica CI Analyzer (catalog 10947347) due to potential false elevated sodium, potassium and chloride test results from incorrect diluent volume display.
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 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 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 Healthcare recalls ADVIA Centaur aTPO Assay kits with specific material numbers and lot numbers due to potential positive bias in patient results at low levels.
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 Healthcare recalls ADVIA Chemistry Microalbumin_2 for potential erroneous low microalbumin test results due to Prozone Effect. Affected units have specific lot numbers and were sold with certain analyzers.
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 recalls Dimension Vista TBIL Flex Reagent Cartridges with lot 23206BA due to potential underfilling during manufacturing, which may affect calibrator and patient results.
Siemens Healthcare recalls ADVIA Chemistry UCFP reagents with potential for biased quality control and patient results. Affected lots include 130414 and 140. No remedy specified in official notice.
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 Healthcare recalls Atellica IM CA 19-9 tests that may show false high results near the upper limit of normal for some samples, particularly in Asia Pacific populations. Affected kits have specific lot numbers and were sold with certain analyzers.
Siemens Healthcare recalls ADVIA Centaur CA 19-9 tests due to potential positive bias in samples near upper limit of normal. This may affect results for CA 19-9 tumor marker testing.
Siemens Healthcare recalls Atellica IM CA 19-9 tests that may show falsely high results near the upper limit of normal for certain samples, particularly in Asia Pacific populations. Affected kits have specific lot numbers and were sold with certain analyzers.
Siemens Healthcare recalls ADVIA Centaur CA 19-9 test kits that may show higher results near the upper limit of normal, affecting some Asian Pacific samples. Consumers should check kit lot numbers and contact Siemens for details.
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 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 recalls IMMULITE 2000 Anti-TG Ab test kits with specific lots that may cause false high thyroid antibody results. Affected kits include catalog # L2KTG6 (600 tests) and lots 785, 790, 791, 793.
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 Healthcare recalls Atellica CH Iron3 analyzers for false high iron results affecting patient tests. Fix by updating software or following specific steps.
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.
