BEUDAMED
    FDA Enforcement Class II Terminated

    VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

    Recall: Z-1107-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1107-2020
    Event ID
    84439
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    December 10, 2019
    Classification Date
    February 7, 2020
    Termination Date
    February 16, 2021
    Address
    100 Rodolphe St, Durham, NC, 27712-9402, United States

    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.

    Code Info

    US Model 30217-01 Lot 1007410330 and 1007393380

    Distribution

    Distributed nationwide and 9 units to Biomerieux Canada.

    Quantity

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