Recall Z-0418-2007 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version 2.0 New User; Part #629636 Software Kit; CXP version 2.0 Upgrade. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and o
| Date | Feb 8, 2007 (initiated Aug 29, 2006) |
| Status | Terminated |
| Reason | Two workflow scenarios associated with renaming regions may produce incorrect results. |
| Root cause | Other |
| Action | A Product Corrective Action (PCA) letter was sent on the week of August 29, 2006 to all accounts that have an FC500 or have ordered CXP or MXP software to inform them that a) incorrect statistics are generated when a polygonal region with vertical re-entrant vertices is renamed using the Region Properties dialog box. b)when a region is copied from one plot to another, and then the new region is renamed, the statistics are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate user preventive action to remedy both issues. A response form is included for |
| Quantity | 397 nationwide |
| Distribution | Nationwide & 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 |