ABX Diagnostices Pentra 60C+ Hematology Analyzer
FDA device recall Z-1149-03 · posted 2003-08-21 · Terminated
Recall details
- Recalling firm
- ABX Diagnostics Inc
- Reason for recall
- Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
- Action taken
- The firm distributed a 'Product Advisory Note' on June 5, 2003 by mail which includes instructions on how to avoid problems. It also mentions a new software release which will fix the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 159
- Distribution
- Nationwide.
- Date initiated
- 2003-06-04
- Date posted
- 2003-08-21
- Date terminated
- 2014-06-17
- Location
- Irvine, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABX PENTRA 60C+ HEMATOLOGY ANALYZER (K003677) | Abx Diagnostics | 2000-12-26 |