VerifyNow PRUTest Platelet Reactivity Test REF 85225 recallZ-0500-2026 · Accriva Diagnostics, Inc. · initiated Oct 21, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Accriva Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to an device without a premarket clearance being incorrectly package and distributed.
FDA root cause category: Under Investigation by firm
What the company is doing
On 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 [email protected].
Recall details
- Recall number
- Z-0500-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 21, 2025
- Posted by the FDA
- Nov 13, 2025
- Recalling firm
- Accriva Diagnostics, Inc.
- Quantity
- 125 boxes (3,125 tests)
- Product code
- JOZ
- FDA submissions
- K141427
- Distribution
- Worldwide - 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.
Product description
VerifyNow 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 (models, lots, serial numbers)
Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VerifyNow Platelet Reactivity Test 85225Accriva Diagnostics Holdings, Inc. · System, Automated Platelet Aggregation1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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