Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VerifyNow P2Y12 Platelet Reactivity Test Recalled by Accriva Diagnostics, Inc. Due to Platelet Reactivity Test distributed without appropriate US-FDA market...
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 P2Y12 Platelet Reactivity Test, REF: 85064
Quantity: 25
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Accriva Diagnostics, Inc.
Accriva Diagnostics, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report