Summary
The FDA issued a Class II for VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 by Accriva Diagnostics, Inc.. Reason: Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurem.
Details
Source
Device Recall
External ID
Z-0961-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Lot/Code Info: UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
Quantity Affected: 25
Reason for Recall
Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
Distribution
US Nationwide distribution in the state of VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-02
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0961-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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