Recall Z-0961-2025— Accriva Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Accriva Diagnostics, Inc., initiated 2024-12-02. FDA's recall record names no specific 510(k) clearance for this event. Product: VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064. Reason: 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..
- Recalling firm
- Accriva Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-02
- Firm location
- San Diego, CA, United States
Product description
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.