Recall Z-0415-03 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
COULTER LH 700 Series Hematology Analyzers
| Date | Jan 9, 2003 (initiated Nov 8, 2002) |
| Status | Terminated |
| Reason | Software vote out logic changed. Erroneous white blood cell counts. |
| Root cause | Other |
| Action | Customers received a telephone call and a faxed Product Corrective Action letter dated Nov. 8, 2002 which includes modified operating instructions. Additionally an updated software version was released and installed on all affected customers units. This recall is complete. |
| Quantity | 132 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |