BEUDAMED
    FDA Recall Terminated

    Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

    Recall: Z-2923-2020 · Initiated July 10, 2020

    Recall

    Recall Number
    Z-2923-2020
    Event Number
    86114
    Firm
    RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom
    FEI Number
    3006697287
    Product Code
    CIJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 10, 2020
    Terminated
    June 17, 2021

    Description

    Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

    Reason

    Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

    Action

    The consumers were sent a letter via email dated July 10, 2020. This notice instructs customers to The distributors and customers will be instructed to: -Discontinue use of batches listed above immediately -Review your reagent inventory of these products and assess your laboratories needs for replacements. Proof of remaining kits will be required. -Discuss the contents of this notice with your Medical Director. -Complete and return the response form

    Distribution

    New Mexico, Massachusetts, WV. Foreign distribution to Bolivia BOSNIA AND HERZEGOVINA Brazil Colombia Costa Rica Cyprus Egypt France Greece Grenada India Iraq Italy Jordan Kazakhstan Kenya Lithuania Mauritius Nepal Nigeria Pakistan Peru Philippines Poland Portugal Qatar Romania Russia South Africa Thailand The Bahamas Turkey UAE UK Vietnam

    Quantity

    1497 units