Reported Nov 19, 2025 · Ongoing

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood…

Accriva Diagnostics, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

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

Is this the product you have?

  • VerifyNow PRUTest Platelet
  • Reactivity Test REF 85225 UDI-DI code10711234150078 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
Lot codes and dates
  • Catalog Number85225
  • UDI-DI code10711234150078
  • Lot NumberWP1559-01
Amount recalled
125 boxes (3,125 tests)

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.