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Open, Classified

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

FDA Recall Z-0961-2025 · Posted 2025-01-16

Recalling FirmAccriva Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeJOZ
Date Initiated2024-12-02
Product Quantity25

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.

Firm Action

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 [email protected] If you have questions regarding replacement product, please contact the firm's Customer Service at 800-955-9525 or e-mail [email protected].

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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