Device recall
Z-0622-2019: Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high…
FDA device recall · Class II · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Key facts
| Recall number (Z-number) | Z-0622-2019 |
|---|---|
| Recall event | 81488 |
| Product | Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. |
| Product code | GKA |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2022 |
| FEI number | 1318354 |
At a glance
- None 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