United StatesThe VerifyNow PRUTest Platelet Reactivity Test (Catalog/REF 85225, UDI-DI 10711234150078, Lot WP1559-01) used to measure platelet P2Y12 receptor blockade is being recalled. Accriva Diagnostics is recalling these kits because the device lacks premarket clearance but was incorrectly packaged and distributed worldwide, including U.S. distribution to AK, CA, FL, IA, IL, MD, MI, NY, SD and TX, and to Hong Kong and Japan.
What's being recalled
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.
Recalling firm: Accriva Diagnostics, Inc., San Diego, CA, United States.
How to identify it
Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
The hazard
Due to an device without a premarket clearance being incorrectly package and distributed.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was 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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada