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Ortho-clinical Diagnostics, Inc. Recalls

57 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Ortho-clinical Diagnostics, Inc..

57Total Recalls
0Critical
846,683Units Affected
Jul 29, 2025Most Recent
All Recalls

Every Ortho-clinical Diagnostics, Inc. Recall

Sorted by most recent. Click any recall for full details.

57 recalls
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Medical Devices·2,320 affected·Jul 29, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-t...
Diagnostic Devices·2,017 affected·Jun 12, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 So...
Diagnostic Devices·37,429 affected·Jun 10, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 So...
Diagnostic Devices·36,005 affected·Jun 10, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: ...
Diagnostic Devices·1,958 affected·May 9, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Medical Devices·3,587 affected·Apr 14, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (Ch...
Diagnostic Devices·1,893 affected·Dec 19, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 69...
Diagnostic Devices·3,249 affected·Dec 19, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbishe...
Diagnostic Devices·981 affected·Dec 19, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Diagnostic Devices·18,467 affected·Jul 3, 2024
RecallFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7...
Diagnostic Devices·1,718 affected·May 14, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Medical Devices·30 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461
Medical Devices·44 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Medical Devices·7 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461
Medical Devices·142 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Diagnostic Devices·1 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System (New and Refurbished)
Medical Devices·1,460 affected·Jan 22, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT7600 Integrated System
Medical Devices·1,720 affected·Jan 22, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Diagnostic Devices·489 affected·Jan 22, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Cal...
Diagnostic Devices·6,920 affected·Nov 27, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
QMS Tacrolimus Calibrators, Product code 10015573
Medical Devices·10 affected·Nov 21, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Medical Devices·51 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Medical Devices·51 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Medical Devices·216 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per car...
Medical Devices·342 affected·Sep 12, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT Chemistry Products ALKP Slides
Medical Devices·402,966 affected·Aug 5, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT Chemistry Products TBIL-ALKP Slides
Medical Devices·52,456 affected·Aug 5, 2023
RecallFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration rang...
Diagnostic Devices·2 affected·May 18, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mm...
Diagnostic Devices·23,751 affected·Apr 17, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Version...
Diagnostic Devices·132 affected·Apr 14, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analy...
Diagnostic Devices·4,895 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of a...
Diagnostic Devices·2,001 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a ...
Diagnostic Devices·1,148 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Ve...
Diagnostic Devices·256 affected·Mar 9, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 ....
Diagnostic Devices·17,396 affected·Oct 13, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Medical Devices·1,148 affected·Jul 19, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Diagnostic Devices·1,575 affected·Mar 25, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Diagnostic Devices·2,502 affected·Mar 25, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Medical Devices·4,125 affected·Dec 10, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Diagnostic Devices·1,416 affected·Nov 22, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer cor...
Medical Devices·865 affected·Mar 26, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemi...
Medical Devices·7,546 affected·Feb 18, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination wi...
Diagnostic Devices·12,177 affected·Feb 12, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen...
Diagnostic Devices·2,782 affected·Feb 12, 2021
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum ...
Medical Devices·9,802 affected·Dec 15, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 ...
Medical Devices·41,598 affected·Dec 11, 2020
High RiskFDA
Ortho-clinical Diagnostics, Inc.
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitat...
Diagnostic Devices·40 affected·Nov 20, 2020
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analyti...
Medical Devices·40 affected·Nov 20, 2020