—#34440

Product

CXP Software Version 1.0 and 1.1 (operating software for Cytomics FD500 Cytometer. Part numbers: 624281, 623560, 623563, 623554, 623555, 623541, 623556, 623557, 623558, 623559.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
Affected lot / code info: Versions 1.0 and 1.1 Serial and lot numbers are not applicable.

Why it was recalled

Software anomaly.

Root cause (FDA determination)

Other

Action the firm took

A recall letter and workaround solution were mailed August 2, 2004. Firm will initiate a software upgrade as well.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2004-08-02
Posted by FDA: 2004-11-30
Terminated: 2012-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34440. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.