Recall Z-2028-2008 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 3 User, Automated differential cell counter; Part Number 774199; Beckman Coulter; Miami, FL 33196.
| Date | Jul 11, 2008 (initiated May 4, 2007) |
| Status | Terminated |
| Reason | Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel. |
| Root cause | Software design |
| Action | Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694. |
| Quantity | 445 units in the US; 56 units in Canada |
| Distribution | Worldwide Distribution including USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.