FDA Device recall Z-0836-2025
Idylla INSTRUMENT, IVD, REF P0010
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Idylla INSTRUMENT, IVD, REF P0010 by Biocartis Nv, citing false-positive MSI-H results generated by the Idylla MSI Test.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0836-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-10 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biocartis Nv |
| Distribution | AL, CA, NJ, OH, TX |
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.
Reason
False-positive MSI-H results generated by the Idylla MSI Test.
Identifiers
| code_info | UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0836-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.