Recall Z-0905-04 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Coulter LH750 Hematology Analyzer. Part Number 6605632.
| Date | Jul 20, 2004 (initiated Mar 31, 2004) |
| Status | Terminated |
| Reason | If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation. |
| Root cause | Other |
| Action | A Product Corrective Action Letter was mailed to all customers who currently have the instrument in thier lab. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occuring. The letter was sent by US Mail on March 31, 2004. |
| Quantity | 981 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011342 | COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc., Jul 9, 2001 |