Device recall
Z-1596-2016: VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1596-2016 |
|---|---|
| Recall event | 73585 |
| Product | VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of… |
| Product code | LON |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 26, 2017 |
| 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