BEUDAMED
    FDA Recall Terminated

    CK MB Calibrator, Catalogue Number CK2393

    Recall: Z-1097-2022 · Initiated March 25, 2022

    Recall

    Recall Number
    Z-1097-2022
    Event Number
    90046
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    CGS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 25, 2022
    Terminated
    December 26, 2023

    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.

    Action

    Firm notified customers via email on March 25, 2022. The distributors and customers were instructed to discard previous target sheet and perform calibration with the realigned target value provided with the letter. Also, to complete and return the response form 12187-QA to [email protected].

    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