VerifyNow P2Y12 Platelet Reactivity Test — Class II medical device recall Z-0961-2025
Ongoing recall by Accriva Diagnostics, Inc., reported 2025-01-22, distributed nationwide. Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel
| Recall number | Z-0961-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accriva Diagnostics, Inc., San Diego, CA, United States |
| Recall initiated | 2024-12-02 |
| Classified | 2025-01-16 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 25 |
| UPC / GTIN / UDI-DI | 10711234150054 |
| Lot numbers | WL1145 |
| Model numbers | 85064 |
| Expiration dates | 2025-10-18 |
Product
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Reason for recall
Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
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-0961-2025. 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.