Recall Z-0039-04 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604
| Date | Oct 15, 2003 (initiated Sep 8, 2003) |
| Status | Terminated |
| Reason | Samples with high fat content will not count platelets accurately. |
| Root cause | Other |
| Action | Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003. |
| Quantity | 36 |
| Distribution | United States and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992511 | ABX PENTRA 60 HEMATOLOGY ANALYZER Abx Diagnostics, Oct 15, 1999 |