BEUDAMED
    FDA Recall Terminated

    Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540

    Recall: Z-2573-2018 · Initiated January 5, 2018

    Recall

    Recall Number
    Z-2573-2018
    Event Number
    80441
    Firm
    Diamedix Corporation
    FEI Number
    1044713
    Product Code
    LJY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 5, 2018
    Terminated
    November 5, 2019
    Address
    14100 Nw 57th Ct, Miami Lakes, FL, 33014-3107

    Description

    Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540

    Reason

    Contains a gel-like contaminant that may affect product performance.

    Action

    Diamedix sent a letter dated January 5th, 2018 was sent to all their customer with the following: Products contains a gel-like contaminant that may affect product performance.An inspection of the product in the Diamedix inventory confirmed this observation. Although, no failed runs have been directly attributed this issue, we feel that the best course of action is to replace the affected diluent. If you are using the reagent lot specified above, please discontinue use immediately. In order to process your replacement, please complete the attached Certificate of Destruction and return this document to Diamedix Customer Service via email: [email protected] or fax to (305) 418- 2321. If you have further questions or concerns you may contact our Technical Service Department at (305) 324-2307 or (800) 433-0945. Please be assured that Diamedix Corporation is working diligently to resolve the issues with this product. We apologize for any inconvenience that this may have caused and we thank you for your continued patience and support. Sincerely, Tracy Chadwrick Director, QA/QC

    Distribution

    AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI

    Quantity

    505