FDA Medical Device Recalls (openFDA)
Accriva Diagnostics, Inc.: 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.
- Recall number
- Z-0500-2026
- Recalling firm
- Accriva Diagnostics, Inc.
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2025-10-21
- Posted
- 2025-11-13
- Terminated
- not on file
- Reason
- Due to an device without a premarket clearance being incorrectly package and distributed.
- Root cause
- Under Investigation by firm
- Action
- 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 customerservice.na@werfen.com.
- Quantity
- 125 boxes (3,125 tests)
- 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.
- Lot, serial or model codes
- Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
- 510(k) numbers
- ["K141427"]
- PMA numbers
- not on file
- Product code
- JOZ
- Firm FEI
- 2250033
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28