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U.S. Department of Health and Human Services

Class 2 Device Recall Bartels ELISA Legionella Urinary Antigen

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 Class 2 Device Recall Bartels ELISA Legionella Urinary Antigensee related information
Date Initiated by FirmJuly 22, 2025
Date PostedAugust 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2292-2025
Recall Event ID 97117
510(K)NumberK991074 
Product Classification Legionella, spp., elisa - Product Code MJH
ProductBartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Code Information Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
Recalling Firm/
Manufacturer		 Trinity Biotech USA
2823 Girts Rd
Jamestown NY 14701-9666
Manufacturer Reason
for Recall		Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
FDA Determined
Cause 2		Under Investigation by firm
ActionTrinity 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 Commerce968 kits
DistributionWorldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MJH
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