Recall Z-0500-2026 ยท JOZ System, Automated Platelet Aggregation
Accriva Diagnostics, Inc.
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.
| Date | Nov 13, 2025 (initiated Oct 21, 2025) |
| Status | Open, Classified |
| Reason | Due to an device without a premarket clearance being incorrectly package and distributed. |
| Root cause | Under Investigation by firm |
| Action | On 10/21/2025, the firm sent via email an "Urgent Medical Device Recall" Letter to customers informing them that Accriva Diagnostics, Inc. has identified that a small number of VerifyNow PRUTest Platelet Reactivity Test (85225) cartridge pouches from lot WP1559-01 may contain VerifyNow P2Y12 Test cartridges. VerifyNow P2Y12 Test cartridges are not cleared by the US-FDA for use in the United States. Customers are instructed to: 1. Please forward this communication to those within your organization who need to become aware of this matter and verify they understand the procedure and can complete |
| Quantity | 125 boxes (3,125 tests) |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST Accumetrics, Inc., Jul 24, 2015 |