Ortho-Clinical Diagnostics, Inc. recalls
Every recall we track for Ortho-Clinical Diagnostics, Inc. — 90 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Ortho-Clinical Diagnostics, Inc. peaked in 2024 (23); 90 since 2017.
All FDA recall records for Ortho-Clinical 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 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 5 | 0 | 5 |
| 2019 | 0 | 0 | 3 | 0 | 3 |
| 2020 | 0 | 1 | 7 | 0 | 8 |
| 2021 | 0 | 0 | 10 | 0 | 10 |
| 2022 | 0 | 0 | 8 | 0 | 8 |
| 2023 | 0 | 6 | 13 | 0 | 19 |
| 2024 | 0 | 1 | 22 | 0 | 23 |
| 2025 | 0 | 1 | 12 | 0 | 13 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Ortho-Clinical 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 Ortho-Clinical Diagnostics, Inc. recalls
54 shown- Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a
Ortho-Clinical recalls VITROS LAC Slides with coating 0130+ due to increased calibration failures causing delayed lab results and potential patient management impacts. Affected units include specific lot numbers and expiration dates.
Ortho-ClinicalJul 29, 2025 - Use cautionMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Ortho-Clinical recalls VITROS Ca Slides (Gen 67+) for increased calibration failures on XT 3400/7600 systems, risking delayed calcium test results and potential patient emergencies.
Ortho-ClinicalJul 9, 2025 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package
Ortho-Clinical recalls VITROS OP Reagent Gen 15 (model 680 1997) due to potential lower quality control results, risking delayed patient testing. Affected units have specific lot numbers and expiration dates.
Ortho-ClinicalJun 12, 2025 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog
Ortho-Clinical recalls VITROS Performance Verifier I models with potential inaccurate QC results due to quality control drift when used with specific enzyme slides. Affected lots may cause delayed patient results or erroneous test results.
Ortho-ClinicalJun 10, 2025 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222;
Ortho-Clinical recalls VITROS XT 7600 Integrated Systems with software versions 3.2 to 3.8.3 due to false expired reagent warnings that can cause inaccurate test results.
Ortho-ClinicalMay 9, 2025 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of
Ortho-Clinical recalls VITROS CRP Slides with incorrect generation code (GEN 88 instead of GEN 83) that could lead to test errors. Affected units have specific lot numbers and catalog codes.
Ortho-ClinicalApr 14, 2025 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software
Ortho-Clinical Diagnostics recalls Solana Bordetella kit (model M308) due to potential false positives in Bordetella parapertussis tests. Affected lots have expiration dates through 2027.
SolanaMar 24, 2025 - Lower riskMedical device
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222
Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated Systems with software version 3.8.0 or higher that may not alert users when reagent packs expire, risking incorrect test results.
VITROSDec 19, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP)
Ortho-Clinical recalls VITROS CRP Slides that may show falsely low results for high CRP samples, risking inaccurate health assessments. Affected units have specific model numbers and expiration dates.
Ortho-ClinicalOct 11, 2024 - Use cautionMedical device
Ortho-Clinical Diagnostics, Inc. recalls The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total
Ortho-Clinical recalls VITROS XT ALB-TP Slides due to dust shedding that may cause inaccurate sodium test results, risking incorrect diagnoses and treatment. All current and expired slides are affected.
Ortho-ClinicalJul 10, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Ortho-Clinical recalls VITROS Folate Reagent Pack 1/2 due to fibrinogen precipitation causing delayed test results. Affected lots include 3380-3480.
Ortho-ClinicalJul 3, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry
Ortho-Clinical recalls VITROS Chemistry Diluent Pack 3 (Lot 01-1645) that may cause inaccurate test results when used with CRP Slides. Affected units include specific model and lot numbers.
Ortho-ClinicalMay 21, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and
Ortho-Clinical recalls VITROS Calibrator Kit 29- In-Vitor with incorrect expiration date (24-Jul-2024) that may cause inaccurate test results if not updated with Assay Data Disk.
Ortho-ClinicalMay 14, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the
Ortho-Clinical recalls VITROS Vitamin B12 Range Verifier Lot 1200 RV Level 2 due to potential range verification failure. No patient results affected; no action needed for most users.
Ortho-ClinicalMay 8, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled
Ortho-Clinical recalls VITROS Anti-HBs Calibrators due to potential for positively biased results over shelf life. Affected lots manufactured between October 2023 and December 2023.
Ortho-ClinicalMar 1, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System, Catalog No. 6844461
Ortho-Clinical recalls VITROS XT 7600 Integrated System software versions 3.8.0 and 3.8.1 due to a defect that may cause QC results to be accepted incorrectly, potentially leading to erroneous patient test results.
Ortho-ClinicalJan 26, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Ortho-Clinical recalls VITROS 5600 Integrated Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include regular and refurbished models with listed serial numbers.
Ortho-ClinicalJan 26, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System (New and Refurbished)
Ortho-Clinical recalls VITROS 5600 Integrated Systems (new and refurbished) due to potential aspiration during sample processing, which may cause incorrect test results. Affected units have specific serial numbers and UDI/DI codes.
Ortho-ClinicalJan 22, 2024 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic
Ortho-Clinical recalls VITROS Anti-HBs Quantitative Reagent Packs (Catalog 6801925) due to potential calibration failures and false elevated results in lab tests. Affected lots include 8931-8990.
Ortho-ClinicalNov 27, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical is recalling QMS Tacrolimus Calibrators (Lot 74859619, exp. May 2024) due to improper storage that may cause inaccurate test results. Affected units could delay critical testing.
Ortho-ClinicalNov 21, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, INc. recalls VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides
Ortho-Clinical recalls VITROS ECO2 Slides with potential for inaccurate CO2 test results. Affected lots may cause overdiagnosis of acidosis or alkalosis, leading to unnecessary treatments. Check product codes and lot numbers for affected items.
Ortho-ClinicalOct 25, 2023 - Use cautionMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Ortho-Clinical recalls VITROS XT 3400 Chemistry System with software version 3.8.0 due to potential delays in critical test results. Affected units may experience screen freezes or printer disconnections, risking treatment delays for patients needing urgent care.
Ortho-ClinicalOct 10, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, INc. recalls VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains
Ortho-Clinical Diagnostics recalls VITROS Lipase Slides with potential for false low or high lipase results, risking missed pancreatitis diagnosis. Affected product codes include 1668409 and 8297749.
Ortho-Clinical DiagnosticsSep 12, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1
Ortho-Clinical recalls VITROS 5,1 chemistry system parts from April 2022 to December 2022 due to potential false test results for Gentamicin and Valproic Acid. Affected units may need replacement to prevent inaccurate patient results.
Ortho-ClinicalAug 9, 2023 - Use cautionMedical device
Ortho-Clinical Diagnostics, INc. recalls VITROS XT Chemistry Products ALKP Slides
Ortho-Clinical Diagnostics recalls VITROS XT ALKP Slides that may give false low liver disease results. Affected units have specific product codes and expiry dates. Stop using if you have these slides to avoid missed diagnoses.
Ortho-Clinical DiagnosticsAug 5, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying
Ortho-Clinical recalls VITROS NT-proBNP II Range Verifiers that may not meet stability requirements after their expiration date, risking inaccurate test results.
Ortho-ClinicalMay 18, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c
Ortho-Clinical recalls VITROS HbA1c Reagent Kits due to potential for both positive and negative HbA1c results, which could lead to misdiagnosis of diabetes. Affected lots listed in the recall notice.
Ortho-ClinicalApr 17, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for
Ortho-Clinical recalls VITROS Calibrator Kit 11 VANC Reagent Generation 50 with affected Assay Data Disk for delayed testing results. Fix by updating to newer software versions.
Ortho-ClinicalApr 14, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of
Ortho-Clinical recalls VITROS 5600 systems where microtip pack caps may not seal properly, causing delayed test results. Affected units have serial numbers J56000143-J56004477.
Ortho-ClinicalMar 10, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks
Ortho-Clinical recalls VITROS SARS-CoV-2 antibody calibrators with incorrect calibrator levels that may delay patient test results. Affected products include specific data release versions and lot numbers.
Ortho-ClinicalMar 9, 2023 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid
Ortho-Clinical recalls VITROS iPTH reagent packs with negative bias in test results. Affected lots may cause inaccurate parathyroid hormone measurements. Contact for remedy details.
Ortho-ClinicalNov 17, 2022 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product
Ortho-Clinical recalls VITROS Chemistry Calibrator Kit 9 (GEN 22) due to calibration errors causing delayed test results. Affected units include specific slide generations and lots.
Ortho-ClinicalOct 13, 2022 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Ortho-Clinical recalls VITROS XT 7600 systems with software version 3.7.2 or older. These systems may report inaccurate test results due to electrical current shifts in the LED. Affected units have product code 6844461.
Ortho-ClinicalJul 19, 2022 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and
Ortho-Clinical recalls SARS-CoV-2 IgG Quantitative Reagent Packs due to incorrect on-analyzer stability time in instructions. This affects lab use on VITROS systems. No action needed per recall.
Ortho-ClinicalMay 26, 2022 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc recalls VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Ortho-Clinical recalls VITROS LH Reagent Packs (lot 1910-1960) due to potential false high or delayed test results. Affected units may cause inaccurate patient and QC results.
Ortho-ClinicalMar 25, 2022 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Ortho-Clinical recalls VITROS VersaTips (Catalog 6801715) due to potential 16% sample volume reduction causing inaccurate blood tests. Affected units may lead to incorrect drug dosing or false positive/negative results for infectious diseases.
Ortho-ClinicalDec 10, 2021 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Ortho-Clinical recalls VITROS High Sample Diluent A Reagent Pack Lot 2190 due to potential inaccurate TSH test results. Affected users should contact the manufacturer for details.
Ortho-ClinicalNov 22, 2021 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of
Ortho-Clinical Diagnostics recalls VITROS Anti-HBc IgM Controls (Lot 1690) due to possible delayed test results from incorrect troubleshooting. No safety risk but may affect lab results.
Ortho-Clinical DiagnosticsOct 15, 2021 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance
Ortho Clinical Diagnostics recalls VITROS SARS-CoV-2 IgG Quantitative Controls that may give delayed test results if used outside expected control range. Affected lots expired by Nov 2021.
Ortho Clinical DiagnosticsSep 10, 2021 - Lower riskMedical device
Ortho-Clinical Diagnostics, INc. recalls VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the
Ortho-Clinical recalls VITROS CoV2 Ag calibrator (Product Code 619995:10758750033591) due to potential calibration failures when used with SARS-CoV-2 Ag Reagent Packs. Affected units may show incorrect test results.
Ortho-ClinicalMay 3, 2021 - Lower riskMedical device
Ortho-Clinical Diagnostics, INc. recalls VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the
Ortho-Clinical recalls VITROS Black Reference Slides (catalog J0231: 9252-0058-3361, 9252-0058-3362) due to incorrect labeling as White Reference Slides. Using these may cause delayed results for most tests.
Ortho-ClinicalMar 26, 2021 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1
Ortho-Clinical recalls VITROS TIBC Calibrator Kits and Fe Slides with potential 80 ug/dL lower TIBC results starting from GEN 26 slides. Affected kits and slides may cause inaccurate blood test results.
Ortho-ClinicalFeb 18, 2021 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used
Ortho-Clinical recalls VITROS SARS-CoV-2 Antigen Reagent Packs that may produce false positive results when used with Remel M4RT Viral Transport Media. Affected kits must be checked for specific product codes and lot numbers.
Ortho-ClinicalFeb 12, 2021 - Lower riskMedical device
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and
Ortho-Clinical recalls VITROS VersaTips from specific lots due to deformities that may cause up to 16% sample measurement errors in lab tests. Affected lots include VITROS 250, 350, ECi, 5,1 FS, 3600, 4600, 5600, and XT7600 models.
Ortho-ClinicalJan 14, 2021 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP)
Ortho Clinical Diagnostics recalls VITROS XT ALB-TP Slides due to potential false protein results. Affected units include all current, future, and past lots of product code 6844293.
Ortho Clinical DiagnosticsDec 15, 2020 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB
Ortho Clinical Diagnostics recalls VITROS CKMB Slides that may cause falsely elevated results due to CK-MM interference. Affected products include 60-slide and 18-slide cartridges with specific product codes and lot numbers.
Ortho Clinical DiagnosticsDec 11, 2020 - Use cautionMedical device
Ortho-Clinical Diagnostics, Inc. recalls enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the
Ortho-Clinical recalls enGen Lab Automation Systems with software versions 4.6 and below due to risk of incorrect patient sample labeling, potentially leading to harmful medical interventions.
Ortho-ClinicalNov 20, 2020 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products
Ortho Clinical Diagnostics recalls VITROS Chemistry Products Performance Verifier II Lot Q7692 for biased ALKP values when stored unopened at refrigerated temperatures. Affected units may need retesting or replacement.
Ortho Clinical DiagnosticsOct 16, 2020 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of
Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 IgG Control products with elevated sample results risk. Affected units may show inaccurate test results; contact for remedy.
Ortho Clinical DiagnosticsSep 30, 2020 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and
Ortho Clinical Diagnostics recalls VITROS Chemistry Calibrator Kit 2 for VITROS 250/350/5,1 FS/4600/XT 3400 systems. This kit may cause inaccurate sodium results in urine tests. Affected lots include 277 (Dec 2019), 288 (May 2020), 298 (Nov 2020), and 219 (Jul 2021).
Ortho Clinical DiagnosticsDec 16, 2019 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium
Ortho Clinical Diagnostics recalls Urine Electrolyte Diluent (Product Code 1112352) due to potential instability when stored in 2mL cups for 7 days. Affected lots have expiry dates from Feb 2020 to Aug 2021.
Ortho Clinical DiagnosticsOct 14, 2019 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic
Ortho Clinical Diagnostics recalls Vitros Myoglobin Calibrators (Product Code 6801043) due to potential calibration failures or atypical quality control results after successful calibration. Affected lots 1271-1310 (expired) and 1315+ (in-date) for VITROS ECi/ECiQ, 3600, and 5600 systems.
Ortho Clinical DiagnosticsNov 29, 2018 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Ortho Clinical Diagnostics recalls VITROS Folate Reagent Packs due to potential biased test results when patients take biotin supplements below the indicated concentration in the instructions.
Ortho Clinical DiagnosticsJul 12, 2018 - Lower riskMedical device
Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS
Ortho Clinical Diagnostics recalls VITROS Performance Verifier II Lot K4852 due to refrigerated stability problems for AST analyte. Affected units may not remain stable after 6 months in the fridge.
Ortho Clinical DiagnosticsJul 10, 2017
Ortho-Clinical Diagnostics, Inc. recall questions
How many recalls has Ortho-Clinical Diagnostics, Inc. had?
90 recalls from Ortho-Clinical Diagnostics, Inc. are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Ortho-Clinical Diagnostics, Inc. recall?
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a, dated Jul 29, 2025. Every Ortho-Clinical Diagnostics, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Ortho-Clinical 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 Ortho-Clinical 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.