CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report

VerifyNow P2Y12 Platelet Reactivity Test recalled by Accriva Diagnostics

Accriva Diagnostics is recalling VerifyNow P2Y12 Platelet Reactivity Test, distributed nationwide in the US. The recall was initiated on 2 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18

Quantity recalled25

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0961-2025
FDA event ID: 96011
Recalling firm: Accriva Diagnostics, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Dec 2024
FDA classified: 16 Jan 2025
Reported: 22 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Dec 2024	Recall initiated by company
16 Jan 2025	Classified by FDA	+45 days
22 Jan 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Where it was distributed

US Nationwide distribution in the state of VA.

Nationwide Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the state of VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Accriva Diagnostics

All 6

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	directCHECK Act-lr whole blood quality control, level recalled	Accriva Diagnostics	Potency & Assay	Nationwide
10 Dec 2025Device	CLASS II	Hemochron Activated Clotting Time Low-Range Test Cuvette recalled	Accriva Diagnostics	Foreign Material	Nationwide
19 Nov 2025Device	CLASS III	VerifyNow PRUTest Platelet Reactivity Test recalled	Accriva Diagnostics	Packaging Defects	Nationwide
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1 Jun 2022Device	CLASS II	The VerifyNow P2Y12 Test is designed to measure platelet recalled	Accriva Diagnostics	Particulate Matter	Nationwide

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