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
FDA Recall Z-0382-2022 · Posted None
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Recalling FirmClark Laboratories, Inc.
Recall StatusTerminated
Product CodeMJH
Date Initiated2021-10-11
Date Terminated2023-03-09
Product Quantity53 units
Reason for Recall
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Firm 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.
Root Cause
Material/Component Contamination
Distribution Pattern
OH, UT
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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