—#49884

Product

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.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K030828
Affected lot / code info: Part Numbers: 722645, 723113, 629637, 629636 Software, Versions 2.0 & 2.1

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide & Canada

Timeline

Recall initiated: 2006-08-29
Posted by FDA: 2007-02-08
Terminated: 2012-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49884. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.