Automated Differential Cell Counter
FDA device recall Z-0003-05 · posted 2004-10-05 · Terminated
Recall details
- Recalling firm
- ABX Diagnostics Inc
- Reason for recall
- Device can generate overestimated platelet results.
- Action taken
- Software problem, device may give overestimated platelet results.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 3
- Distribution
- Nationwide
- Date initiated
- 2004-08-13
- Date posted
- 2004-10-05
- Date terminated
- 2005-09-02
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PENTRA 80 (K024002) | Abx Diagnostics | 2003-01-03 |