VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Recall
- Recall Number
- Z-0961-2025
- Event Number
- 96011
- Firm
- Accriva Diagnostics, Inc.
- FEI Number
- 2250033
- Product Code
- JOZ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- December 2, 2024
- Posted
- January 16, 2025
- Address
- 6260 Sequence Dr, San Diego, CA, 92121-4358
Description
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
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 [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].
US Nationwide distribution in the state of VA.
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