ACCESS Estradiol Reagent Test System
FDA device recall Z-0872-03 · posted 2003-05-29 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Short volume, resulting possibility of falsely elevated results.
- Action taken
- Consignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHP
- Quantity affected
- 1593 kits
- Distribution
- Nationwide and Canada
- Date initiated
- 2003-05-08
- Date posted
- 2003-05-29
- Date terminated
- 2003-10-14
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973743) | Beckman Instruments, Inc. | 1997-10-31 |