Bartels Legionella urinary antigen kits may contain particulate matter
Bartels ELISA Legionella Urinary Antigen kits are being recalled because two lots have the potential to contain particulate matter. 968 kits are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall over possible particulate matter in a laboratory test kit, with no incorrect result or clinical consequence stated.
Plain-English summary
The Bartels ELISA Legionella Urinary Antigen test kit, model number B1029-440, UDI-DI 05391516744065, an in vitro diagnostic test for the presumptive diagnosis of past or current Legionnaires' Disease, is being recalled. The action covers 968 kits from lots 065 and 066.
The stated reason is the potential for the kits to contain particulate matter. The FDA classified the action as Class II. The source does not describe a resulting result or clinical consequence.
Distribution was worldwide, including nationwide in the United States in Maryland and Utah.
Laboratories should identify affected stock using the model number, UDI-DI and lot numbers above and follow the instructions issued by the manufacturer.
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
- Affected units
- 968
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
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