Recall Z-1018-04 ยท JOZ System, Automated Platelet Aggregation
Accumetrics Inc
VerifyNow Asprin Assay Kit Part No. 85034
| Date | Jul 20, 2004 (initiated May 10, 2004) |
| Status | Terminated |
| Reason | Test results too low in control. |
| Root cause | Other |
| Action | Letters were sent FEDEX on May 10, 2004. Customers were requested to discard the product. Distributors opted to return product. A response form was included to track materials. |
| Quantity | 4500 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012701 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) Accumetrics, Inc., Jun 12, 2002 |