Primus Corporation dba Trinity Biotech
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0349-2023 | Class III | A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1 | October 5, 2021 |
| Z-0350-2023 | Class III | Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0 | October 5, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K112015 | PREMIER HB9210 HBA1C ANALYZER | November 22, 2011 |