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ImmuView S. pneumoniae and L. pneumophila urinary antigen test
Ssi Diagnostica A/S · Model 10557 · UDI-DI 05713106105573
10
510(k) clearances
5
Adverse events (2 deaths)
3
Recalls
17
Facilities
Description
Urinary antigen test
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-22 | Trinity Biotech USA | Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter. |
| 2021-10-11 | Clark Laboratories, Inc. | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay |
| 2006-09-29 | Inverness Medical Professional Diagnostics | Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.