Device recall
Z-1464-2024: VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial…
FDA device recall · Class I · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1464-2024 |
|---|---|
| Recall event | 94264 |
| Product | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i)… |
| Product code | LON |
| Recalling firm | Biomerieux Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K161217 |
| FEI number | 1950204 |
At a glance
- 1–9 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