Beckman Coulter Inc CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis Software Kit V2.1, 3 User Pack; Part #722398 CXP Analysis Software Kit V2.1, 5 User Pack; Part #722399 CXP Analysis Software Kit V2. 1, 15 User Pack; Part # 722593 CXP Analysis Software Kit V2.1, 5 Network User Pack Part #722594 CXP Analysis Software Kit V2.1, 10 Network User Pack; Part #722595 CXP Analysi Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Two workflow scenarios associated with renaming regions may produce incorrect results.

Recommended Action

Per FDA guidance

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.