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Recall Observatory FDA recall evidence

Device product

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Z-0961-2025

December 02, 2024

Class II

Product summary

Firm
Accriva Diagnostics, Inc.
Event
Event 96011
Status
Ongoing
Classification
Class II
Quantity
25
Official record key
device-enforcement:Z-0961-2025

Official wording

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.

Code information: UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18

Distribution pattern: US Nationwide distribution in the state of VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.