Ortho Clinical Diagnostics Inc
Raritan, NJ
This page shows every FDA and USDA recall linked to Ortho Clinical Diagnostics Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
26
Total Recalls
2017
First Recall
2023
Most Recent
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (AD...
May 30, 2023
· Device
Active
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemogl...
May 24, 2023
· Device
Active
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qu...
May 4, 2023
· Device
Active
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody
Calibrators programmed onto the Assay Data D...
Apr 18, 2023
· Device
Active
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides
For in vitro diagnostic use only.
P...
Nov 10, 2022
· Device
Active
VITROS Immunodiagnostic Products LH Reagent Pack
Product Code: 1350198
Mar 25, 2022
· Device
Active
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD
1931922
Mar 25, 2022
· Device
Active
VITROS Immunodiagnostic Products Prolactin Reagent Pack
Product Code: 1849793
Mar 25, 2022
· Device
Active
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)-
For use in monitoring the p...
Sep 10, 2021
· Device
Terminated
VITROS Chemistry Products CKMB Slides:
(1)VITROS CKMB Slides (60 Slide cartridge)
Product Code:8058232...
Jan 5, 2021
· Device
Active
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (...
Dec 15, 2020
· Device
Terminated
VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VI...
Dec 15, 2020
· Device
Terminated
VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products P...
Oct 16, 2020
· Device
Active
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid i...
Sep 30, 2020
· Device
Terminated
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the perfor...
Sep 30, 2020
· Device
Terminated
VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry S...
Dec 16, 2019
· Device
Terminated
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay val...
Oct 14, 2019
· Device
Terminated
Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis...
Oct 14, 2019
· Device
Terminated
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodia...
Nov 29, 2018
· Device
Terminated
VITROS Immunodiagnostic Products - Prolactin Reagent Pack
(10758750000111) 1849793
Jul 12, 2018
· Device
Active
VITROS Immunodiagnostic Products - FSH Reagent Pack
(10758750000302) 1931922
Jul 12, 2018
· Device
Active
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Jul 12, 2018
· Device
Active
VITROS Immunodiagnostic Products - TSH Reagent Pack
(10758750000227) 1912997
Jul 12, 2018
· Device
Active
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VIT...
Jul 10, 2017
· Device
Terminated