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Ortho-clinical Diagnostics, Inc. Recalls

57 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Ortho-clinical Diagnostics, Inc..

57Total Recalls
0Critical
846,683Units Affected
Jul 29, 2025Most Recent
All Recalls

Every Ortho-clinical Diagnostics, Inc. Recall

Sorted by most recent. Click any recall for full details.

57 recalls
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immuno...
Diagnostic Devices·691 affected·Sep 30, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals w...
Diagnostic Devices·651 affected·Sep 30, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7...
Medical Devices·39,709 affected·Dec 16, 2019
High RiskFDA
Ortho Clinical Diagnostics Inc
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS...
Diagnostic Devices·4,030 affected·Nov 29, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Diagnostic Devices·7,880 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
Diagnostic Devices·1,955 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
Diagnostic Devices·1,790 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
Diagnostic Devices·68,230 affected·Jul 12, 2018
RecallFDA
Ortho Clinical Diagnostics Inc
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 460...
Diagnostic Devices·10,021 affected·Jul 10, 2017