Ortho-Clinical Diagnostics, Inc.: 30 recalls on record

Recalls filed with 1 agency: FDA (30).

First recall on record: October 10, 2018. Most recent: December 4, 2024.

Risk classification: Class II: 28 · Class III: 2

Most recent recalls

DateAgencyProduct
December 4, 2024FDAVITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-react…Z-0535-2025
August 28, 2024FDAThe VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an a…Z-2684-2024
August 21, 2024FDAVITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2Z-2580-2024
July 10, 2024FDAVITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS…Z-2245-2024
July 10, 2024FDAVITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Desc…Z-2266-2024
June 19, 2024FDAVITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pac…Z-2142-2024
June 12, 2024FDAVITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly.…Z-2019-2024
March 13, 2024FDAVITROS XT 7600 Integrated System, Catalog No. 6844461Z-1233-2024
March 13, 2024FDAVITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbish…Z-1224-2024
March 13, 2024FDAVITROS 3600 Immunodiagnostic System (New and Refurbished)Z-1220-2024
March 13, 2024FDAVITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)Z-1230-2024
March 13, 2024FDAVITROS XT 3400 Chemistry System, Catalog No. 6844458Z-1232-2024
March 13, 2024FDAVITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbish…Z-1229-2024
March 13, 2024FDAVITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)Z-1231-2024
March 13, 2024FDAVITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)Z-1226-2024
March 13, 2024FDAVITROS XT7600 Integrated SystemZ-1222-2024
March 13, 2024FDAVITROS XT 3400 Chemistry System, Catalog No. 6844458Z-1227-2024
March 13, 2024FDAVITROS XT 7600 Integrated System, Catalog No. 6844461Z-1228-2024
March 13, 2024FDAVITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)Z-1225-2024
March 13, 2024FDAVITROS 5600 Integrated System (New and Refurbished)Z-1221-2024
January 31, 2024FDAVITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 …Z-0772-2024
January 17, 2024FDAQMS Tacrolimus Calibrators, Product code 10015573Z-0712-2024
December 20, 2023FDAVITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Ru…Z-0544-2024
November 15, 2023FDAVITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Ca…Z-0236-2024
May 10, 2023FDAVITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, a…Z-1556-2023

Questions about this company

How many recalls does Ortho-Clinical Diagnostics, Inc. have?
Recalert has 30 U.S. recalls on record for Ortho-Clinical Diagnostics, Inc., published between October 10, 2018 and December 4, 2024.
What was the most recent Ortho-Clinical Diagnostics, Inc. recall?
FDA recall Z-0535-2025, published December 4, 2024: VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
Which agencies have handled Ortho-Clinical Diagnostics, Inc. recalls?
Ortho-Clinical Diagnostics, Inc. appears as the recalling firm in recalls from: FDA (30).

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