Trinity Biotech USA
FDA Regulatory Profile
Trinity Biotech USA appears in FDA public data with 1 recall, 11 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2292-2025, Class II) was initiated on July 22, 2025. Its most recent 510(k) clearance was granted on May 22, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 11
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2292-2025 | Class II | Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit f | July 22, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140455 | CAPTIA MEASLES IGM | May 22, 2014 |
| K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | July 13, 2004 |
| K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT | July 13, 2004 |
| K033083 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | November 26, 2003 |
| K033067 | PYLORI IGG | November 26, 2003 |
| K033070 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | November 26, 2003 |
| K033079 | CHLAMYDIA IGG ELISA TEST SYSTEM | November 26, 2003 |
| K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | November 26, 2003 |
| K033064 | MYCOPLASMA IGG | November 26, 2003 |
| K993839 | ENA PROFILE ELISA TEST SYSTEM | January 12, 2000 |
| K992665 | MACRA LP(A) ENZYME IMMUNOASSAY KIT | November 26, 1999 |