BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0924-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0924-2018
    Event ID
    79181
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wiener Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 14, 2018
    Initiation Date
    November 10, 2017
    Classification Date
    March 7, 2018
    Address
    Street, N/A, Riobamba, N/A, N/A, Argentina

    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.

    Code Info

    Product Code 1293254, Lot Code 1709228140

    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