VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code:… — Class III medical device recall Z-0500-2026
Ongoing recall by Accriva Diagnostics, Inc., reported 2025-11-19, distributed nationwide. Due to an device without a premarket clearance being incorrectly package and distributed.
| Recall number | Z-0500-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accriva Diagnostics, Inc., San Diego, CA, United States |
| Recall initiated | 2025-10-21 |
| Classified | 2025-11-13 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK, JP |
| UPC / GTIN / UDI-DI | 10711234150078 |
| Lot numbers | WP1559-01 |
| Model numbers | 85225 |
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 for recall
Due to an device without a premarket clearance being incorrectly package and distributed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0500-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.