Recall Z-0298-06 ยท GKZ Counter, Differential Cell
ABX Diagnostics Inc
Pentra 80 and Pentra 80XL Hematology Analyzers
| Date | Dec 23, 2005 (initiated Apr 8, 2004) |
| Status | Terminated |
| Reason | Software defect, instrument may erroneously give a result of '0' or '---'. |
| Root cause | Other |
| Action | Firm sent a notification/recall letter on April 8, 2004. They plan to modify the software in August 2004. |
| Quantity | 67 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.