VerifyNow P2Y12 Platelet Test (Accriva) – Market Clearance Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Brand
Accriva Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
Products Sold
UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
Accriva Diagnostics, Inc. is recalling VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 due to Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurem. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026