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U.S. Department of Health and Human Services

Class 3 Device Recall VerifyNow PRU Platelet Reactivity Test

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 Class 3 Device Recall VerifyNow PRU Platelet Reactivity Testsee related information
Date Initiated by FirmOctober 21, 2025
Date PostedNovember 13, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0500-2026
Recall Event ID 97863
510(K)NumberK141427 
Product Classification System, automated platelet aggregation - Product Code JOZ
ProductVerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
Code Information Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
FEI Number 2250033
Recalling Firm/
Manufacturer		 Accriva Diagnostics, Inc.
6260 Sequence Dr
San Diego CA 92121-4358
For Additional Information ContactPaula Morgan
858-263-2590
Manufacturer Reason
for Recall		Due to an device without a premarket clearance being incorrectly package and distributed.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 10/21/2025, the firm sent via email an "Urgent Medical Device Recall" Letter to customers informing them that Accriva Diagnostics, Inc. has identified that a small number of VerifyNow PRUTest Platelet Reactivity Test (85225) cartridge pouches from lot WP1559-01 may contain VerifyNow P2Y12 Test cartridges. VerifyNow P2Y12 Test cartridges are not cleared by the US-FDA for use in the United States. Customers are instructed to: 1. Please 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. Please check your inventory to determine if you have any boxes of VerifyNow PRU Platelet Reactivity Test (85225), lot number WP1559-01. If you have this product in stock, do NOT use. 4. Please sort through your inventory to identify if your inventory is affected. 5. Please destroy all impacted boxes and document on the enclosed form. 6. Please read the instructions on the Tracking Form and complete and return the form to Accriva Diagnostics, Inc. 7. If you have questions regarding replacement product, please contact Customer Service at 1-800-955-9525 or e-mail customerservice.na@werfen.com.
Quantity in Commerce125 boxes (3,125 tests)
DistributionWorldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.
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.
510(K) Database510(K)s with Product Code = JOZ
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