CLASS III ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report

VerifyNow PRUTest Platelet Reactivity Test recalled

Accriva Diagnostics is recalling VerifyNow PRUTest Platelet Reactivity Test, distributed nationwide in the US. The recall was initiated on 21 Oct 2025 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesCatalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01

Quantity recalled125 boxes (3,125 tests)

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-0500-2026
FDA event ID: 97863
Recalling firm: Accriva Diagnostics, San Diego, CA
Classification: Class III
Status: Ongoing
Recall initiated: 21 Oct 2025
FDA classified: 13 Nov 2025
Reported: 19 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

21 Oct 2025	Recall initiated by company
13 Nov 2025	Classified by FDA	+23 days
19 Nov 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

Due to an device without a premarket clearance being incorrectly package and distributed.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.

Where it was distributed

Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.

Nationwide Alaska California Florida Iowa Illinois Maryland Michigan New York South Dakota Texas

Questions about this recall

Why was it recalled?

Due to an device without a premarket clearance being incorrectly package and distributed.

Which lots are affected?

Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01

Where was it sold?

Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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
22 Jan 2025Device	CLASS II	VerifyNow P2Y12 Platelet Reactivity Test recalled by Accriva Diagnostics	Accriva Diagnostics	Other	Nationwide
6 Nov 2024Device	CLASS II	AVOXimeter 1000E, Product Number: AVOX1000E recalled	Accriva Diagnostics	Device Malfunction	AZ
1 Jun 2022Device	CLASS II	The VerifyNow P2Y12 Test is designed to measure platelet recalled	Accriva Diagnostics	Particulate Matter	Nationwide

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