Accriva Diagnostics, Inc. has recalled 25 units of the VerifyNow P2Y12 Platelet Reactivity Test (REF: 85064) because the device was distributed without the necessary market clearance from the U.S. Food and Drug Administration (FDA). Healthcare personnel may be using this test to manually calculate a patient's platelet inhibition levels using measurements that have not been officially cleared for that purpose. No incidents or injuries have been reported related to this recall.
Because this test lacks FDA clearance, its accuracy and performance have not been formally validated for manual calculations of platelet aggregation inhibition. If healthcare providers rely on unverified results, it could lead to incorrect medical decisions regarding a patient's drug therapy with blood-thinning medications.
Recall #: Z-0961-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.