Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1
This recall has been terminated (originally issued November 21, 2006).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- July 26, 2006
- Posted
- November 21, 2006
- Terminated
- February 29, 2012
- Recall Number
- Z-0197-2007
- Quantity
- 416 (US) + 60 (Canada)
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide and Canada
Lot / Code Info
Part Numbers: 722645 Software Kit; CXP version 2.1 New User; 723113 Software Kit; CXP version 2.1 Upgrade; 629637 Software Kit; CXP version 2.0 New User; 629636 Software Kit; CXP version 2.0 Upgrade; 626553 TN; FC500 WITH UPS; 6605627 TN; 5 CLR, FC500 (IOOV); 6605628 TN; 5 CLR, FC500 (120V); 6605629 TN; 5 CLR, FC500 (220V); 6605630 TN;5 CLR, FC500 (240V)
Root Cause
Other
Action Taken
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.