BEUDAMED
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    VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code QKO·March 9, 2023

    VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code PPM·November 22, 2021

    VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DLJ·April 14, 2023

    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJX·May 18, 2023

    VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DKB·October 13, 2022

    VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802915

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·March 10, 2023

    VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802413

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·March 10, 2023

    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·July 19, 2022

    VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6844461

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·March 10, 2023

    VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·July 19, 2022

    VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code LOM·November 27, 2023

    QMS Tacrolimus Calibrators, Product code 10015573

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JIT·November 21, 2023

    VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CGJ·July 12, 2018

    VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CGN·July 12, 2018

    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code JLW·July 12, 2018

    VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CFT·July 12, 2018

    Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. Product Code: 6199960

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code QKO·May 26, 2022

    VITROS XT Chemistry Products ALKP Slides

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code CJE·August 5, 2023

    VITROS XT Chemistry Products TBIL-ALKP Slides

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code CIG·August 5, 2023

    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc·Product code CGJ·March 25, 2022