Manufacturer

Ortho-Clinical Diagnostics, Inc.

63 recalls in our database name Ortho-Clinical Diagnostics, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–63 of 63

HighFDA (Devices)·Z-1628-2023·2023-05-31
VITROS Chemistry HbA1c Reagent Kit recalled due to inaccurate test results
Ortho-Clinical Diagnostics is recalling VITROS Chemistry HbA1c Reagent Kits due to potential for false-positive and false-negative results, which may lead to misdiagnosis.
Product
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1556-2023·2023-05-10
VITROS 5600 system pack opener assembly may not function properly
The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.
Product
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnosti
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1557-2023·2023-05-10
VITROS 5600 Integrated System MicroTip Pack Opener Assembly Defect
Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.
Product
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1555-2023·2023-05-10
VITROS XT 7600 Analyzer Pack Opener May Not Remove Reagent Pack Caps
The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.
Product
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagn
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1396-2023·2023-04-26
VITROS COVID-19 Antibody Test Calibrators Recalled for Incorrect Calibrator Levels
Ortho-Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total N Antibody Calibrators used in COVID-19 testing due to incorrect calibrator levels in Assay Data Disks, which can delay patient test results.
Product
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0878-2023·2023-01-11
VITROS Intact PTH Reagent Pack recalled for negatively biased measurement results
Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.
Product
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0220-2023·2022-11-16
Diagnostic Calibrator Kit Recalled for Software Defect Affecting System Calibration
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.
Product
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2022·2022-09-14
VITROS XT 3400 Chemistry System May Produce Inaccurate Test Results
The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.
Product
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1676-2022·2022-09-14
Laboratory diagnostic system may report inaccurate results during shutdown
The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.
Product
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1367-2022·2022-07-20
Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions
Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.
Product
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0735-2022·2022-03-16
Laboratory diagnostic tips recalled for potential dispensing errors
Ortho-Clinical Diagnostics is recalling VITROS Chemistry VersaTips due to shape deformity that may reduce sample volume by 16%. Undetected errors could result in inaccurate test results for bloodborne infectious disease assays.
Product
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2022·2022-01-26
VITROS High Sample Diluent A Reagent Produces Lower Than Expected Results
Ortho-Clinical Diagnostics is recalling VITROS High Sample Diluent A Reagent Pack Lot 2190 because it produces lower than expected TSH test results. The recall affects 1,416 units distributed worldwide.
Product
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0247-2022·2021-11-24
VITROS Immunodiagnostic Anti-HBc Controls Recalled Due to Incorrect Booklet Information
Ortho-Clinical Diagnostics recalled 191 units of VITROS Anti-HBc IgM Controls (Lot 1690) because the Controls Values booklet contained incorrect product information. Although patient test result accuracy is not affected, there is potential for delayed quality control troubleshooting.
Product
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
Category
Medical Device
Distribution
19 states