VerifyNow Asprin Assay Kit Part No. 85034
FDA device recall Z-1018-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Accumetrics Inc
- Reason for recall
- Test results too low in control.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOZ
- Quantity affected
- 4500
- Distribution
- Nationwide.
- Date initiated
- 2004-05-10
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-07
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) (K012701) | Accumetrics, Inc. | 2002-06-12 |