Ortho-Clinical Diagnostics, Inc.
58 recalls on record · Latest: Sep 24, 2025
FDA Devices Moderate Nov 25, 2020
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adapt…
FDA Devices Moderate Feb 19, 2020
VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrat…
FDA Devices Moderate Feb 27, 2019
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immuno…
FDA Devices Moderate Oct 10, 2018
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
FDA Devices Moderate Oct 10, 2018
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
FDA Devices Moderate Oct 10, 2018
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
FDA Devices Moderate Oct 10, 2018
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
FDA Devices Low Mar 7, 2018