VerifyNow PRUTest (Accriva) – Unauthorized Device Distribution (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Accriva Diagnostics, Inc.
Lot Codes / Batch Numbers
Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
Products Sold
Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
Accriva Diagnostics, Inc. is recalling VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUT due to Due to an device without a premarket clearance being incorrectly package and distributed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to an device without a premarket clearance being incorrectly package and distributed.
Recommended Action
Per FDA guidance
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 the enclosed forms. 2. In addition, forward the enclosed customer notification to all other organizations where affected devices may have been transferred to. 3. Please check your inventory to determine if you have any boxes of VerifyNow PRU Platelet Reactivity Test (85225), lot number WP1559-01. If you have this product in stock, do NOT use. 4. Please sort through your inventory to identify if your inventory is affected. 5. Please destroy all impacted boxes and document on the enclosed form. 6. Please read the instructions on the Tracking Form and complete and return the form to Accriva Diagnostics, Inc. 7. If you have questions regarding replacement product, please contact Customer Service at 1-800-955-9525 or e-mail customerservice.na@werfen.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026