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U.S. Department of Health and Human Services

Class 2 Device Recall VerifyNow P2Y12 Platelet Reactivity Test

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 Class 2 Device Recall VerifyNow P2Y12 Platelet Reactivity Testsee related information
Date Initiated by FirmDecember 02, 2024
Date PostedJanuary 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0961-2025
Recall Event ID 96011
Product Classification System, automated platelet aggregation - Product Code JOZ
ProductVerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Code Information UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
Recalling Firm/
Manufacturer		 Accriva Diagnostics, Inc.
6260 Sequence Dr
San Diego CA 92121-4358
For Additional Information Contact
858-263-2300
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce25
DistributionUS Nationwide distribution in the state of VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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