FDA Recall Terminated

Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version 2.0 New User; Part #629636 Software Kit; CXP version 2.0 Upgrade. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.

Recall: Z-0418-2007 · Initiated August 29, 2006

Recall

Recall Number
Z-0418-2007
Event Number
37083
Firm
Beckman Coulter Inc
FEI Number
2050012
Product Code
GKZ
Status
Terminated
Root Cause
Other
Initiated
August 29, 2006
Posted
February 8, 2007
Terminated
April 19, 2012
Address
200 S Kraemer Blvd, Brea, CA, 92822-6208

Description

Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version 2.0 New User; Part #629636 Software Kit; CXP version 2.0 Upgrade. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.

Reason

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

Action

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.

Distribution

Nationwide & Canada

Quantity

397 nationwide