VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole bl
Summary
The FDA issued a Class III for VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 1071123415007 by Accriva Diagnostics, Inc.. Reason: Due to an device without a premarket clearance being incorrectly package and distributed..
Details
Source
Device Recall
External ID
Z-0500-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
Quantity Affected: 125 boxes (3,125 tests)
Reason for Recall
Due to an device without a premarket clearance being incorrectly package and distributed.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-21
Company
San Diego, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Accriva Diagnostics, Inc. has 8 FDA actions in our database, including 6 recalls and 2 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accriva Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accriva Diagnostics, Inc. have FDA actions?
Accriva Diagnostics, Inc. has 8 FDA actions in our database, including 6 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0500-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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