Device recall
Z-0349-2023: A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c…
FDA device recall · Class III · Primus Corporation dba Trinity Biotech
Key facts
| Recall number (Z-number) | Z-0349-2023 |
|---|---|
| Recall event | 91054 |
| Product | A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis |
| Product code | JPK |
| Recalling firm | Primus Corporation dba Trinity Biotech |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 9, 2023 |
| 510(k) numbers | K952720 |
| FEI number | 1931251 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database