FDA Device recall Z-0500-2026
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the la…
- FDA Device
- Class III
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class III recall of VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the la… by Accriva Diagnostics, citing due to an device without a premarket clearance being incorrectly package and distributed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0500-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-10-21 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Accriva Diagnostics |
| Distribution | US |
Product
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
Reason
Due to an device without a premarket clearance being incorrectly package and distributed.
Identifiers
| code_info | Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01 |
|---|
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-0500-2026%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.