FDA Device recall Z-0961-2025
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 by Accriva Diagnostics, citing platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0961-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-02 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Accriva Diagnostics |
| Distribution | US |
Product
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Reason
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.
Identifiers
| code_info | UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18 |
|---|
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-0961-2025%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.