FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2292-2025
- Recalling firm
- Trinity Biotech USA
- Product
- Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
- Status
- Open, Classified
- Initiated
- 2025-07-22
- Posted
- 2025-08-12
- Terminated
- not on file
- 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 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.
- 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.
- Lot, serial or model codes
- Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
- 510(k) numbers
- ["K991074"]
- PMA numbers
- not on file
- Product code
- MJH
- Firm FEI
- 1318354
- Firm city
- Jamestown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28