VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Reported: January 22, 2025 Initiated: December 2, 2024 #Z-0961-2025
Product Description
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
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.
Details
- Recalling Firm
- Accriva Diagnostics, Inc.
- Units Affected
- 25
- Distribution
- US Nationwide distribution in the state of VA.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064. Recalled by Accriva Diagnostics, Inc.. Units affected: 25.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0961-2025.
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