Device recall
Z-0962-2019: Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF…
FDA device recall · Class II · Organon Teknika Inc
Key facts
| Recall number (Z-number) | Z-0962-2019 |
|---|---|
| Recall event | 81934 |
| Product | Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF… |
| Product code | LON |
| Recalling firm | Organon Teknika Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 6, 2020 |
| FEI number | 1950204 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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