FDA Medical devices recall ·
VerifyNow PRUTest Platelet Reactivity Test recall
- Recall number
- Z-0500-2026
- Date
- (initiated October 21, 2025)
- Company / brand
- Accriva Diagnostics, Inc.
6260 Sequence Dr, San Diego, CA, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 125 boxes (3,125 tests)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to an device without a premarket clearance being incorrectly package and distributed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
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.
States: Alaska California Florida Iowa Illinois Maryland Michigan New York South Dakota Texas
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-0500-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.