Recall Z-0961-2025 ยท JOZ System, Automated Platelet Aggregation
Accriva Diagnostics, Inc.
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
| Date | Jan 16, 2025 (initiated Dec 2, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 25 |
| Distribution | US Nationwide distribution in the state of VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.