BEUDAMED
    FDA Recall Terminated

    VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

    Recall: Z-1107-2020 · Initiated December 10, 2019

    Recall

    Recall Number
    Z-1107-2020
    Event Number
    84439
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    LFY
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    December 10, 2019
    Terminated
    February 16, 2021
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

    Reason

    Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.

    Action

    Users are instructed via customer letter to stop using the VIDAS VZG batches 1007410330 and 1007393380 and destroy the remaining products.

    Distribution

    Distributed nationwide and 9 units to Biomerieux Canada.

    Quantity

    1,218 US units total (726 US, 492 OUS)