Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1: Part #731419 KIT; FOC MXP 2.0 UPGRADE KIT; Part #731418 SWRE KIT; MXP 2.0 NEW USER; Part #772145 MXP 2.1 FOC Upgrade Kit; 771938 MXP 2.1 Software; Part #771952 FOC MXP 2.1 Upgrade Kit; Part #771953 New User MXP 2.1 Kit. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
This recall has been terminated (originally issued February 8, 2007).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- August 29, 2006
- Posted
- February 8, 2007
- Terminated
- April 19, 2012
- Recall Number
- Z-0419-2007
- Quantity
- 26 units nationwide
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Two workflow scenarios associated with renaming regions may produce incorrect results.
Distribution
Nationwide & Canada
Lot / Code Info
Part Numbers: 731419, 731418, 772145, 771938, 771952, 771953. Software, Versions 2.0 & 2.1
Root Cause
Other
Action Taken
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 consignees to return to recalling firm.