Ortho Clinical Diagnostics recalls
Ortho Clinical Diagnostics appears in 311 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
FDA Device · Class II · 2023-08-16 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Troponin I ES Calibrators
FDA Device · Class II · 2023-08-16 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only
FDA Device · Class III · 2023-08-02 · Ortho Clinical Diagnostics - VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only
FDA Device · Class II · 2023-07-19 · Ortho Clinical Diagnostics - VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions…
FDA Device · Class II · 2023-06-07 · Ortho Clinical Diagnostics - VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol…
FDA Device · Class II · 2023-05-31 · Ortho Clinical Diagnostics - VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of ana…
FDA Device · Class II · 2023-05-10 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analyte…
FDA Device · Class II · 2023-05-10 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a var…
FDA Device · Class II · 2023-05-10 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versi…
FDA Device · Class II · 2023-04-26 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in huma…
FDA Device · Class II · 2023-01-11 · Ortho Clinical Diagnostics - VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only
FDA Device · Class II · 2022-11-16 · Ortho Clinical Diagnostics - VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
FDA Device · Class II · 2022-09-14 · Ortho Clinical Diagnostics - VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
FDA Device · Class II · 2022-09-14 · Ortho Clinical Diagnostics - Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600…
FDA Device · Class II · 2022-07-20 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
FDA Device · Class II · 2022-05-25 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
FDA Device · Class II · 2022-05-25 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
FDA Device · Class II · 2022-05-25 · Ortho Clinical Diagnostics - VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box
FDA Device · Class II · 2022-03-16 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
FDA Device · Class II · 2022-01-26 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3…
FDA Device · Class III · 2021-11-24 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/E…
FDA Device · Class II · 2021-10-27 · Ortho Clinical Diagnostics - VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection…
FDA Device · Class II · 2021-06-02 · Ortho Clinical Diagnostics - VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer corre…
FDA Device · Class II · 2021-05-05 · Ortho Clinical Diagnostics - VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only)
FDA Device · Class II · 2021-03-31 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic
FDA Device · Class II · 2021-03-24 · Ortho Clinical Diagnostics - VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with…
FDA Device · Class II · 2021-03-24 · Ortho Clinical Diagnostics - VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWe…
FDA Device · Class II · 2021-03-03 · Ortho Clinical Diagnostics - VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum an…
FDA Device · Class II · 2021-01-20 · Ortho Clinical Diagnostics - VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3…
FDA Device · Class II · 2021-01-20 · Ortho Clinical Diagnostics - enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative…
FDA Device · Class II · 2021-01-13 · Ortho Clinical Diagnostics - VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytica…
FDA Device · Class II · 2021-01-13 · Ortho Clinical Diagnostics - VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cart…
FDA Device · Class II · 2021-01-13 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals wit…
FDA Device · Class II · 2020-11-25 · Ortho Clinical Diagnostics - VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an ass…
FDA Device · Class III · 2020-11-25 · Ortho Clinical Diagnostics - VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodi…
FDA Device · Class II · 2020-11-25 · Ortho Clinical Diagnostics - VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in s…
FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics - VITROS XT3400 Chemistry System, Product code 6844458
FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics - VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chem…
FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics - VITROS XT7600 Integrated System, Product code 6844461
FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics - VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only
FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics - VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vi…
FDA Device · Class II · 2020-08-19 · Ortho Clinical Diagnostics - VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in…
FDA Device · Class II · 2020-08-19 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vi…
FDA Device · Class II · 2020-06-24 · Ortho Clinical Diagnostics - VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use o…
FDA Device · Class II · 2020-06-24 · Ortho Clinical Diagnostics