Recall Z-1149-03 ยท GKZ Counter, Differential Cell
ABX Diagnostics Inc
ABX Diagnostices Pentra 60C+ Hematology Analyzer
| Date | Aug 21, 2003 (initiated Jun 4, 2003) |
| Status | Terminated |
| Reason | Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door. |
| Root cause | Other |
| Action | 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. |
| Quantity | 159 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003677 | ABX PENTRA 60C+ HEMATOLOGY ANALYZER Abx Diagnostics, Dec 26, 2000 |