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    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (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

    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

    Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (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 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 Nos. 6802783 (regular) and 6802914 (refurbished)

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

    Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

    FDA Recall
    Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code JJE·April 7, 2020

    Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

    FDA Recall
    Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code JJE·April 7, 2020

    Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·May 7, 2020

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·January 26, 2023

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Recall
    Open, Classified ·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code JJE·July 10, 2024

    ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJE·April 24, 2025

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·March 27, 2025

    Alinity ci-series System Control Module, REF: 03R70-01

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code JJE·May 30, 2023

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·February 29, 2024

    Atellica IM 1600 Analyzer, SMN 11066000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code JJE·September 28, 2021

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·June 25, 2025

    DxI 9000 Access Immunoassay Analyzer C11137

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·May 7, 2025

    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·May 9, 2025

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·October 1, 2025

    Alinity ci Level Sensor, Bulk Solution

    FDA Recall
    Open, Classified ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019