BEUDAMED
    FDA Recall 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 · Initiated August 12, 2019

    Recall

    Recall Number
    Z-3026-2020
    Event Number
    86364
    Firm
    Zeus Scientific, Inc.
    FEI Number
    2242436
    Product Code
    MYM
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    August 12, 2019
    Terminated
    May 20, 2022
    Address
    199 Evans Way, Branchburg, NJ, 08876-4600

    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.

    Action

    Pending. The firm has not initiated customer notification for this issue.

    Distribution

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

    Quantity

    74