Bartels ELISA Legionella Urinary Antigen diagnostic test kits recalled for particulate contamination
Trinity Biotech USA recalls Bartels ELISA Legionella Urinary Antigen diagnostic test kits due to potential particulate matter contamination. Approximately 968 kits in lot numbers 065 and 066 were distributed in the United States and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving potential particulate matter contamination that could compromise the performance and accuracy of a diagnostic test used to detect Legionnaires' Disease, a serious respiratory infection. Although no illnesses or injuries have been reported, this constitutes a risk-of-harm product that meets the rubric criterion for a High severity rating.
Plain-English summary
Trinity Biotech USA is recalling Bartels ELISA Legionella Urinary Antigen test kits (Model B1029-440) due to potential particulate matter contamination in lot numbers 065 and 066. These in vitro diagnostic test kits are used for the presumptive diagnosis of past or current Legionnaires' Disease through urinary antigen detection.
Approximately 968 kits were distributed worldwide. In the United States, distribution occurred in Maryland and Utah. International distribution includes France, Germany, Ireland, Israel, Kuwait, Latvia, and the United Kingdom.
The recalled product
- 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.
- Manufacturer
- Trinity Biotech USA
- Hazard
- particulate-matter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
Distribution
Distributed nationwide across the United States.
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