BEUDAMED
    FDA Enforcement Class III Terminated

    CK MB Calibrator, Catalogue Number CK2393

    Recall: Z-1097-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1097-2022
    Event ID
    90046
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 25, 2022
    Initiation Date
    March 25, 2022
    Classification Date
    May 16, 2022
    Termination Date
    December 26, 2023
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    CK MB Calibrator, Catalogue Number CK2393

    Reason

    Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.

    Code Info

    GTIN 05055273201451 Lot 4410CK

    Distribution

    Domestic distribution to WV and PR. International distribution to Bangladesh, Bosnia & Herzegovina, Botswana, China, Colombia, Costa Rica, Croatia, Egypt, Fiji, France, Georgia, Germany, Ghana, Greece, Grenada, Hong Kong, India, Iraq, Italy, Lithuania, Malaysia, Maldives, Malta, Mexico, Morocco, Mozambique, Nepal, Nigeria, Pakistan, Philippines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, South Korea, Switzerland, Thailand, Turkey, UK, Uruguay, Uzbekistan and Vietnam.

    Quantity

    1,392