Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 Recalled by Accriva Diagnostics, Inc. Due to Due to an device without a premarket clearance...

Date: October 21, 2025
Company: Accriva Diagnostics, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Accriva Diagnostics, Inc. directly.

Affected Products

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.

Quantity: 125 boxes (3,125 tests)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Accriva Diagnostics, Inc.

Accriva Diagnostics, Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report