Recall Z-1377-05 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0
| Date | Aug 17, 2005 (initiated Jul 6, 2005) |
| Status | Terminated |
| Reason | Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results. |
| Root cause | Other |
| Action | Letters issued to users on July 13, 2005 which also included modified operating instructions, and response cards. |
| Quantity | 36 |
| Distribution | USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.