Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diag
FDA device recall Z-2292-2025 · posted 2025-08-12 · Open, Classified
Recall details
- Recalling firm
- Trinity Biotech USA
- Reason for recall
- Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
- Action taken
- Trinity Biotech initially notified consignees 06/05/2025 via letter. Consignees were instructed to inspect the conjugate bottles before use in both manual and automated testing and if any are observed with particulate matter, Trinity Biotech confirms the kit performs, and results are consistent with release specifications and IFU claims. However, replacement can be requested. Trinity Biotech notified consignees again on about 07/22/2025 via an updated URGENT: MEDICAL DEVICE Notification letter. Consignees were instructed that their trained laboratory technicians should inspect the conjugate bottles before use in both manual and automated testing, if any bottle is observed to contain conjugate with particulate matter, to discard the bottle and use a clear bottle available. If there are no other available clear bottles, please contact Trinity Biotech for a replacement kit. The current conjugate will be replaced with Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 067 once available.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MJH
- Quantity affected
- 968 kits
- Distribution
- Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
- Date initiated
- 2025-07-22
- Date posted
- 2025-08-12
- Location
- Jamestown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST (K991074) | Intracel Corp. | 1999-12-21 |