Device recall
Z-2095-2017: ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-2095-2017 |
|---|---|
| Recall event | 76983 |
| Product | ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States) |
| Product code | JWY |
| Recalling firm | BioMerieux SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2022 |
| 510(k) numbers | K020748 |
| FEI number | 1000611339 |
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