Device recall
Z-0836-2025: Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid…
FDA device recall · Class II · Biocartis Nv
Key facts
| Recall number (Z-number) | Z-0836-2025 |
|---|---|
| Recall event | 96022 |
| Product | Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges. |
| Product code | OOI |
| Recalling firm | Biocartis Nv |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3009972873 |
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