Device recall
Z-2012-2021: ACE Control Set - IVD Control set for the quantitative determination of…
FDA device recall · Class III · Sentinel CH SpA
Key facts
| Recall number (Z-number) | Z-2012-2021 |
|---|---|
| Recall event | 88040 |
| Product | ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001 |
| Product code | JJX |
| Recalling firm | Sentinel CH SpA |
| Recall class | Class III |
| Status | Open, Classified |
| FEI number | 3000303338 |
At a glance
- None 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