BEUDAMED
    FDA Recall Terminated

    Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440

    Recall: Z-0382-2022 · Initiated October 11, 2021

    Recall

    Recall Number
    Z-0382-2022
    Event Number
    89088
    Firm
    Clark Laboratories, Inc.
    FEI Number
    1318354
    Product Code
    MJH
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    October 11, 2021
    Terminated
    March 9, 2023
    Address
    2823 Girts Rd, Jamestown, NY, 14701-9666

    Description

    Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440

    Reason

    Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay

    Action

    Trinity Biotech notified customers by Customer Recall letter dated 10/11/21 states reason for recall, health risk and action to take: Customers are instructed to complete the attached fax back form indicating how many of this kit lot you have in your inventory and you will receive replacement from another lot. A thorough investigation into the root cause has been initiated and any corrective/preventive actions will be implemented as appropriate. If you have any questions or comments arising from this customer communication, the Trinity Biotech Help Desk is ready to answer your questions (800-325-3424, option 2). to destroy the kit and offered replacement product of a different lot. Any results obtained from a valid assay may be reported do not require repeat testing.

    Distribution

    OH, UT

    Quantity

    53 units