Class III U.S. Food and Drug Administration

Accriva Diagnostics, Inc. VerifyNow Prutest Platelet Reactivity Test REF 85225 Udi-Di recall: Due to an device without a premarket clearance being incorrectly package

Recall published 11 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to an device without a premarket clearance being incorrectly package and distributed.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0500-2026
Published
November 19, 2025
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Accriva Diagnostics, Inc.
Product type
Medical devices
Units affected
125 boxes (3,125 tests)
Distribution
Nationwide
Made in
United States
Lot / code info
Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
UPC codes
10711234150078

Products covered by this recall

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.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10711234150078

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • WP1559-01 — 125 boxes

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Accriva Diagnostics, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Accriva Diagnostics, Inc. — 6260 Sequence Dr, San Diego, CA, 92121-4358

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Accriva Diagnostics, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10711234150078; lot code WP1559-01 — 125 boxes. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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