FDA Medical devices recall ·
VerifyNow P2Y12 Platelet Reactivity Test recall
- Recall number
- Z-0961-2025
- Date
- (initiated December 2, 2024)
- Company / brand
- Accriva Diagnostics, Inc.
6260 Sequence Dr, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 25
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Why was it recalled?
Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
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
UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
Distribution
US Nationwide distribution in the state of VA.
States: Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0961-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.