BEUDAMED
    FDA Enforcement Class II Ongoing

    biokitHSV-2 Rapid Test, REF: 300028001

    Recall: Z-1021-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1021-2023
    Event ID
    91384
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biokit, S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2023
    Initiation Date
    September 28, 2022
    Classification Date
    January 26, 2023
    Address
    Avinguda De Can Montcau 7, (Barcelona), Llica D'Amunt, N/A, N/A, Spain

    Description

    biokitHSV-2 Rapid Test, REF: 300028001

    Reason

    HSV-2 rapid test may report false positive results.

    Code Info

    UDI-DI/Lots - Expiration Dates: 08426951056439/ B34243 - 2022-09-30, B34309 - 2022-11-30, B34463 - 2022-11-30, B34465 - 2023-02-28, B35052 - 2023-05-31, B35188 - 2023-07-31, B35398 - 2023-10-31

    Distribution

    US Nationwide distribution in the states of NY, CA, IN, NC, VA.

    Quantity

    2,393