BEUDAMED
    FDA Recall Open, Classified

    Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

    Recall: Z-0924-2018 · Initiated November 10, 2017

    Recall

    Recall Number
    Z-0924-2018
    Event Number
    79181
    Firm
    Wiener Laboratories Street Riobamba Argentina
    FEI Number
    3001026625
    Product Code
    MIU
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 10, 2017

    Description

    Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

    Reason

    Internal program testing shows that product may not reach the indicated expiration date.

    Action

    On about November 10, 2017, customers were notified via email of the recall. Instructions include to examine inventory and cease distribution of the device, make arrangements to return affected devices, acknowledge receipt of the recall notification, and notify customers if further distributed.

    Distribution

    Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.

    Quantity

    1,563 units