Recall Z-0455-2009 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2
| Date | Jan 7, 2009 (initiated Aug 1, 2007) |
| Status | Terminated |
| Reason | Software error: The recall was initiated after Beckman Coulter identified that the CXP User documentation does not adequately characterize the use of the Live Gate feature. The primary use of a Live Gate is for the international removal of unwanted events, such as debris. The data outside of the Live Gate will not be stored to the final listmode file, this reducing the data set size. The softwa |
| Root cause | Software design |
| Action | The customer notifications were initiated by Beckman Coulter on July 23, 2007 when a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers that the user documentation does not adequately characterize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate and actions to be taken. For further information, please contact Beckman Coulter, Inc. by telephone at 714-993-5321. |
| Quantity | 565 |
| Distribution | Globally to the 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 |