BEUDAMED
    FDA Recall Open, Classified

    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

    Recall: Z-0471-2021 · Initiated October 16, 2020

    Recall

    Recall Number
    Z-0471-2021
    Event Number
    86669
    Firm
    Ortho Clinical Diagnostics Inc
    FEI Number
    2250051
    Product Code
    JJY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 16, 2020
    Address
    1001 US Highway 202, Raritan, NJ, 08869-1424

    Description

    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

    Reason

    Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

    Action

    Ortho Clinical Diagnostics issued letter IMPORTANT PRODUCT CORRECTION NOTIFICATION (CL2020-243) on 16 October 2020 via FedEx/US Priority Mail or ORTHO Plus e-Communications for delivery on October 19, 2020, stating reason for recall, health risk and action to take: If their laboratory used VITROS Performance Verifier II Lot Q7692 to verify performance of VITROS ALKP Slides and stores an inventory of unopened vials in the refrigerator: Discard any remaining refrigerated inventory of unopened VITROS Performance Verifier II Lot Q7692. If their laboratory does not store inventory of VITROS Performance Verifier II Lot Q7692 in the refrigerator or does not use Lot Q7692 to verify performance of VITROS ALKP Slides: No Action Is Required. To verify performance of VITROS ALKP Slides, use frozen (never refrigerated) inventory of VITROS Performance Verifier II Lot Q7692 or switch to another lot of VITROS Performance Verifier II. Ortho will replace or credit your account as indicated on your Confirmation of Receipt form Retain this notification as verification of the revised instructions. OUS notified by email on 09/14/20 to global affiliates for distribution to distributors and customers.

    Distribution

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

    Quantity

    10788 total: US 4680; OUS 6108