BEUDAMED
    FDA Enforcement Class II Terminated

    ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.

    Recall: Z-3026-2020 · Reported October 7, 2020

    Enforcement

    Recall Number
    Z-3026-2020
    Event ID
    86364
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zeus Scientific, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 7, 2020
    Initiation Date
    August 12, 2019
    Classification Date
    September 29, 2020
    Termination Date
    May 20, 2022
    Address
    199 Evans Way, N/A, Branchburg, NJ, 08876-4600, United States

    Description

    ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.

    Reason

    FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.

    Code Info

    Lot 19040014

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada.

    Quantity

    74