VerifyNow P2Y12 Platelet Reactivity Test distributed without FDA market clearance
Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an unapproved diagnostic device distributed without required market clearance. This is a risk-of-harm product where clinical decision-making could be based on unvalidated test results, but no illnesses or injuries have been reported.
Plain-English summary
The VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 (Lot WL1145, expiration 2025-10-18), manufactured by Accriva Diagnostics, Inc., is the subject of this recall. The test was distributed nationwide in Virginia without obtaining the required US FDA market clearance.
This diagnostic test measures platelet reactivity in patients receiving P2Y12 receptor inhibitor medications. Healthcare professionals using this test could perform baseline measurements prior to starting drug therapy and then use a provided percent inhibition formula to manually calculate a patient's platelet aggregation inhibition percentage to guide treatment decisions.
The product was distributed and used without FDA approval or validation. Using an unapproved diagnostic device to make clinical decisions presents a risk of patient harm through potentially inaccurate or unvalidated test results. No illnesses or injuries have been reported to date.
The recalled product
- Product
- VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
- Manufacturer
- Accriva Diagnostics, Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- unapproved-device
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
Distribution
Distributed nationwide across the United States.
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