PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
FDA device recall Z-1342-04 · posted 2004-08-13 · Terminated
Recall details
- Recalling firm
- ABX Diagnostics Inc
- Reason for recall
- Power failure having impact on software.
- Action taken
- Firm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJH
- Quantity affected
- 81
- Distribution
- Nationwide.
- Date initiated
- 2004-06-24
- Date posted
- 2004-08-13
- 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 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 (K022200) | Abx Diagnostics | 2002-07-29 |