FDA Medical Device Recalls (openFDA)
Accriva Diagnostics, Inc.: VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
- Recall number
- Z-0961-2025
- Recalling firm
- Accriva Diagnostics, Inc.
- Product
- VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
- Status
- Open, Classified
- Initiated
- 2024-12-02
- Posted
- 2025-01-16
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 25
- Distribution
- US Nationwide distribution in the state of VA.
- Lot, serial or model codes
- UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
- 510(k) numbers
- not on file
- 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