Recall Z-0197-2007 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1
| Date | Nov 21, 2006 (initiated Jul 26, 2006) |
| Status | Terminated |
| Reason | Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition. |
| Root cause | Other |
| Action | Customer letter -- A Product Corrective Action (PCA) letter was sent the week of July 24, 2006 to all accounts that have FC500 with CXP Software 2.0 and 2.1 to inform them that a potential sample misidentification may occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlines actions to be taken to avoid mis-identification of patient results. |
| Quantity | 416 (US) + 60 (Canada) |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030828 | TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) Beckman Coulter, Inc., May 21, 2003 |