Recall Z-0317-2007 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit
| Date | Dec 27, 2006 (initiated Oct 17, 2006) |
| Status | Terminated |
| Reason | The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle. |
| Root cause | Other |
| Action | A Product Corrective Action (PCA) letter was mailed on Oct 17, 2006 to FC500 MPL and MXP software accounts. They are informed that if the operator opens the Parameter Selection Dialogue box after parameters have been selected for the RATIO Parameter, the selected parameters could revert back to the default choices. If these same parameters were used in the creation of the RATIO Parameter in any other saved protocol, the protocols will also be changed once they are opened after the error occurs. An immediate user preventive action to remedy this issue each time acquisition of samples that requi |
| Quantity | 37 units in the US; 4 units in Canada |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.