Accriva Diagnostics, Inc. recalls VerifyNow P2Y12 Platelet Reactivity Test

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.

On 12/02/2024, a recall notice was mailed to the customer who was asked to do the following: 1.Forward this communication to those within your organization who need to become aware of this matter and verify they understand the procedure and can complete the enclosed forms. 2. In addition, forward the enclosed customer notification to all other organizations where affected devices may have been transferred to. 3. Destroy all impacted boxes. 4. Complete and return the tracking form via email to ilsd_ra.na@werfen.com If you have questions regarding replacement product, please contact the firm's Customer Service at 800-955-9525 or e-mail customerservice.na@werfen.com.

• FDA enforcement recordOfficial FDA database entry for Z-0961-2025
• FDA device classification · JOZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.5700The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Accriva Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.