BEUDAMED
    FDA Recall Terminated

    VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 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

    Recall: Z-1290-2019 · Initiated February 20, 2019

    Recall

    Recall Number
    Z-1290-2019
    Event Number
    82311
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 20, 2019
    Terminated
    September 15, 2021
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 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

    Reason

    Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems

    Action

    Ortho Clinical Diagnostics (Ortho) issued an "URGENT PRODUCT CORRECTION NOTIFICATION" , a customer letter (Ref. CL2019-052) dated 21 February 2019 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to customers who were shipped affected VITROS Systems/or whose VITROS System has a luminometer parts replacement. The customers were notified of the issue and instructed to notify Ortho upon experiencing the issue described: -Avoid performing a shutdown/restart on your systems unless directed by an Ortho representative or prompted by condition code help text. -If you shutdown/restart and encounter any of the above Luminometer condition codes and are unable to process MicroWell assays, immediately contact the Ortho Care" Technical Solutions Center for service to your system. -Complete the enclosed Confirmation of Receipt form no later than March 1, 2019 by Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: [email protected]. -Please forward this notification if the product was distributed outside of your facility. Foreign affiliates were informed by email on 21 February 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take. Questions contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.

    Quantity

    28 UNITS