Device recall
Z-0590-2021: InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT)…
FDA device recall · Class II · Enterix, Inc.
Key facts
| Recall number (Z-number) | Z-0590-2021 |
|---|---|
| Recall event | 86674 |
| Product | InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01. |
| Product code | KHE |
| Recalling firm | Enterix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2023 |
| 510(k) numbers | K170548 |
| FEI number | 3003224146 |
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