Recall Z-0129-2009 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
| Date | Jan 13, 2009 (initiated Oct 11, 2007) |
| Status | Terminated |
| Reason | Software error: This field action was initiated after Beckman Coulter determined that the CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user should refresh the dataset after changes are made. |
| Root cause | Software design |
| Action | Software error: A Product corrective Action (PCA) letter was mailed via US Postal Service on October 17, 2007 to all Cytomics FC 500 Flow Cytometry System with CXP Software accounts. This letter was entitled "URGENT: PRODUCT CORRECTIVE ACTION." Customers were informed that the user documentation does not clearly state that the user should refresh the dataset after changes are made. The letters provide the customers with an explanation and action to be taken whenever a protocol containing data is modified by making changes to cytosettings, regions or gates. Customer were instructed to review |
| Quantity | 594 Worldwide: 518 in the United States and 76 in Canada |
| Distribution | Globally - United States 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 |