Ortho-Clinical Diagnostics: 119 recalls on record

Recalls filed with 1 agency: FDA (119).

First recall on record: August 1, 2012. Most recent: April 3, 2024.

Risk classification: Class II: 110 · Class III: 9

Most recent recalls

DateAgencyProduct
April 3, 2024FDAVITROS Performance Verifier IIZ-1373-2024
April 3, 2024FDAVITROS Performance Verifier IZ-1372-2024
September 2, 2020FDAVITROS XT3400 Chemistry System, Product code 6844458Z-2878-2020
September 2, 2020FDAVITROS XT7600 Integrated System, Product code 6844461Z-2879-2020
September 2, 2020FDAVITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic …Z-2875-2020
July 8, 2020FDAVITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802…Z-2480-2020
June 24, 2020FDAVITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 107587500045…Z-2366-2020
November 13, 2019FDAVITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reage…Z-0269-2020
August 14, 2019FDAVITROS 5600 Integrated System, clinical chemistry analyzerZ-2179-2019
May 15, 2019FDAVITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For us…Z-1289-2019
May 1, 2019FDAVITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usag…Z-1222-2019
March 20, 2019FDAVITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic u…Z-0992-2019
October 10, 2018FDAVITROS Sodium Slides, Catalog # 837 9034Z-3280-2018
September 19, 2018FDAVITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vit…Z-3043-2018
December 20, 2017FDAenGen Track System with TCAutomation Software Version 4.2Z-0254-2018
April 19, 2017FDAVITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- O…Z-1765-2017
March 22, 2017FDAVITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (1…Z-1471-2017
February 15, 2017FDAVITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in …Z-1181-2017
February 8, 2017FDAVITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ S…Z-1117-2017
September 21, 2016FDAThe VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITR…Z-2804-2016
August 24, 2016FDAVITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 29…Z-2580-2016
June 15, 2016FDAVITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quant…Z-1913-2016
June 15, 2016FDAVITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758…Z-1914-2016
April 13, 2016FDAVITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 107587500071…Z-1348-2016
March 16, 2016FDAVITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 1075…Z-1072-2016

Questions about this company

How many recalls does Ortho-Clinical Diagnostics have?
Recalert has 119 U.S. recalls on record for Ortho-Clinical Diagnostics, published between August 1, 2012 and April 3, 2024.
What was the most recent Ortho-Clinical Diagnostics recall?
FDA recall Z-1373-2024, published April 3, 2024: VITROS Performance Verifier II
Which agencies have handled Ortho-Clinical Diagnostics recalls?
Ortho-Clinical Diagnostics appears as the recalling firm in recalls from: FDA (119).

Do you carry products from Ortho-Clinical Diagnostics? Check your whole catalog free against 80,000+ recalls.

Paste up to 100 UPCs or SKUs and see which ones match a CPSC, FDA, NHTSA or FSIS recall. No account needed.

Check my catalog free

Want it checked every night instead? Starter watches 500 SKUs for $29/month. See plans

Related companies