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    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020

    VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0

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

    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 6, 2016

    VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 6, 2013

    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 19, 2014

    VITROS 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·February 20, 2019

    Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code JJE·December 19, 2024

    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 3, 2015

    VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 --- NOTE: VITROS 3600 that are e-Connected are not affected by this issue. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 13, 2011

    Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)

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