Ortho-Clinical Diagnostics, Inc.
58 recalls on record · Latest: Sep 24, 2025
FDA Devices Moderate Sep 24, 2025
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
FDA Devices Moderate Jul 23, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Versi…
FDA Devices Moderate Jul 23, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Versi…
FDA Devices Moderate Jul 9, 2025
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid…
FDA Devices Moderate Jul 9, 2025
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 …
FDA Devices Moderate Jun 4, 2025
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
FDA Devices Moderate Jan 29, 2025
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Softwa…
FDA Devices Moderate Jan 29, 2025
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China…
FDA Devices Moderate Jan 29, 2025
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 …
FDA Devices Moderate Aug 21, 2024
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
FDA Devices Low Jul 10, 2024
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrat…
FDA Devices Moderate Mar 13, 2024
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
FDA Devices Moderate Mar 13, 2024
VITROS XT 7600 Integrated System, Catalog No. 6844461
FDA Devices Moderate Mar 13, 2024
VITROS 5600 Integrated System (New and Refurbished)
FDA Devices Moderate Mar 13, 2024
VITROS XT7600 Integrated System
FDA Devices Moderate Mar 13, 2024
VITROS XT 3400 Chemistry System, Catalog No. 6844458
FDA Devices Moderate Mar 13, 2024
VITROS 3600 Immunodiagnostic System (New and Refurbished)
FDA Devices Moderate Mar 13, 2024
VITROS XT 7600 Integrated System, Catalog No. 6844461
FDA Devices Moderate Mar 13, 2024
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Devices Moderate Jan 31, 2024
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Ca…
FDA Devices Moderate Jan 17, 2024
QMS Tacrolimus Calibrators, Product code 10015573
FDA Devices Moderate Dec 20, 2023
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
FDA Devices Moderate Dec 20, 2023
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
FDA Devices Moderate Dec 20, 2023
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
FDA Devices Moderate Nov 15, 2023
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
FDA Devices Moderate Sep 27, 2023
VITROS XT Chemistry Products ALKP Slides
FDA Devices Moderate Sep 27, 2023
VITROS XT Chemistry Products TBIL-ALKP Slides
FDA Devices Low Aug 2, 2023
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VIT…
FDA Devices Moderate Jun 7, 2023
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 621…
FDA Devices Moderate May 31, 2023
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemog…
FDA Devices Moderate May 10, 2023
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clini…
FDA Devices Moderate May 10, 2023
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of c…
FDA Devices Moderate May 10, 2023
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of a…
FDA Devices Moderate Apr 26, 2023
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV)…
FDA Devices Moderate Nov 16, 2022
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Che…
FDA Devices Moderate Sep 14, 2022
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
FDA Devices Moderate Sep 14, 2022
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
FDA Devices Moderate May 25, 2022
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
FDA Devices Moderate May 25, 2022
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
FDA Devices Moderate Mar 16, 2022
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
FDA Devices Moderate Jan 26, 2022
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
FDA Devices Moderate May 5, 2021
VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction fact…
FDA Devices Moderate Mar 31, 2021
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems…
FDA Devices Moderate Mar 24, 2021
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITRO…
FDA Devices Moderate Mar 24, 2021
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pac…
FDA Devices Moderate Jan 20, 2021
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma u…
FDA Devices Moderate Jan 13, 2021
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurem…
FDA Devices Moderate Jan 13, 2021
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample p…
FDA Devices Moderate Jan 13, 2021
VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartri…
FDA Devices Moderate Nov 25, 2020