BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

    Recall: Z-0914-2018 · Initiated September 22, 2017

    Recall

    Recall Number
    Z-0914-2018
    Event Number
    79155
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305841
    Product Code
    DIF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 22, 2017
    Terminated
    August 24, 2020
    Address
    1000 Lee Road, Rochester, NY, 14606

    Description

    VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

    Reason

    This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.

    Action

    On September 18, 2017 a letter was sent to customers who received the BENZ reagent within the past 18 months of affected lots. The letter stated that customers may continue use of the product if QC results using VITROS DAT Performance Verifiers are within established ranges for each assay. If QC BENZ results are below established ranges, the customer should discontinue use of the product. The letter requests customers post the notification by each system that processes the VITROS BENZ Reagent. If the product was transferred outside of the facility, to notify those customers as well. Affected lots will be replaced in 6-8 weeks. Questions or concerns can be directed to 585-453-3452

    Distribution

    Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

    Quantity

    196