Accriva Diagnostics, Inc. recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 Th…

Due to an device without a premarket clearance being incorrectly package and distributed.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0500-2026
• FDA 510(k) clearance · K141427The device's official FDA premarket clearance record
• FDA device classification · JOZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.5700The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Accriva Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.