Recall Z-2292-2025 ยท MJH Legionella, Spp., Elisa
Trinity Biotech USA
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
| Date | Aug 12, 2025 (initiated Jul 22, 2025) |
| Status | Open, Classified |
| Reason | Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 968 kits |
| Distribution | Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST Intracel Corp., Dec 21, 1999 |