Device recall
Z-1236-2026: VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1236-2026 |
|---|---|
| Recall event | 98268 |
| Product | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405… |
| Product code | LTW |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172944, K183360, K183415, K193567, K211136 |
| FEI number | 1950204 |
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