BEUDAMED
    FDA Enforcement Class III Ongoing

    Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

    Recall: Z-2311-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2311-2021
    Event ID
    88287
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cell Marque Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 25, 2021
    Initiation Date
    July 15, 2021
    Classification Date
    August 18, 2021
    Address
    6600 Sierra College Blvd, N/A, Rocklin, CA, 95677-4306, United States

    Description

    Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

    Reason

    Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.

    Code Info

    Item/Lot: 324M-15/0000116695, 324M-16/0000116696

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.

    Quantity

    20