BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    Recall: Z-0807-2018 · Initiated July 10, 2017

    Recall

    Recall Number
    Z-0807-2018
    Event Number
    78724
    Firm
    Ortho Clinical Diagnostics Inc
    FEI Number
    2250051
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    July 10, 2017
    Terminated
    August 6, 2020
    Address
    1001 US Highway 202, Raritan, NJ, 08869-1424

    Description

    VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    Reason

    VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.

    Action

    On July 10, 2017 the firm sent notification letters and an e-communications to their customers. Foreign customers were notified by email. Customers were instructed to complete a response form with the amount of product on hand and to discontinue use of the recalled product. For further questions, please call (585) 453-3452.

    Distribution

    Worldwide

    Quantity

    10,021 units