BEUDAMED
    FDA Recall Open, Classified

    biokitHSV-2 Rapid Test, REF: 300028001

    Recall: Z-1021-2023 · Initiated September 28, 2022

    Recall

    Recall Number
    Z-1021-2023
    Event Number
    91384
    Firm
    Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain
    FEI Number
    3002806557
    Product Code
    LGC
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 28, 2022
    Posted
    January 26, 2023

    Description

    biokitHSV-2 Rapid Test, REF: 300028001

    Reason

    HSV-2 rapid test may report false positive results.

    Action

    On 9/28/22, Werfen Field Action notices were emailed to customers who were asked to 1) Stop using and discard affected kits, 2) Complete and return the tracking form provided with the notice to [email protected], 3) Forward the notice to all affected facilities. On 2/10/23, Werfen Field Action notices were emailed to additional customers informing them of an additional affected lot. On 3/13/23, Werfen Field Action notices were emailed to an additional customer informing them of an additional affected lot. On 4/11/23, Werfen Field Action notices were emailed to an additional customer informing them of an additional affected lot.

    Distribution

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

    Quantity

    2,393