Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive d
Summary
The FDA issued a Class II for Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro D by Trinity Biotech USA. Reason: Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter..
Details
Source
Device Recall
External ID
Z-2292-2025
Action Date
2025-08-20
Status
Ongoing
Category
device
Product Description
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Lot/Code Info: Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
Quantity Affected: 968 kits
Reason for Recall
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Distribution
Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-22
Company
Jamestown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Trinity Biotech USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Trinity Biotech USA have FDA actions?
This is the only FDA action we have on record for Trinity Biotech USA in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2292-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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