Bartels Legionella Urinary Antigen- an adjunct to culture… recallZ-0382-2022 · Clark Laboratories, Inc. · initiated Oct 11, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Clark Laboratories, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-0382-2022
- Status
- Terminated
- Initiated by the company
- Oct 11, 2021
- Recalling firm
- Clark Laboratories, Inc.
- Quantity
- 53 units
- Product code
- MJH
- FDA submissions
- K991074
- Distribution
- OH, UT
Product 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
Code information (models, lots, serial numbers)
Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Trinity Biotech B1029-440Clark Laboratories, Inc. · Legionella, Spp., Elisa2 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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