Z-2292-2025Class II

Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the...

Name: Z-2292-2025 Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the...
Creator: Trinity Biotech USA
Published: 2025-07-22
License: https://open.fda.gov/license/

Trinity Biotech USA / initiated 2025-07-22 / Open, Classified

FDA source

Trinity Biotech USA began a recall of Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires... on 2025-07-22. FDA classified it as Class II and gives the reason as "Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2292-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-22
Posted: 2025-08-12
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.
Product code: MJH Legionella, Spp., Elisa
Reason for recall: Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
FDA 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 in commerce: 968 kits
Distribution: Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
Product codes and lots: Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2292-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2292-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-12

Product code MJH

K991074Class IIBartels Legionella Urinary Antigen Elisa TestIntracel Corp. / cleared 1999-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)