Recalls / —

—#35835

Product

CXP software for Cytomics FC500 Cytometer

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

Affected lot / code info

Versions 1.0, 1.1, and 2.0

Why it was recalled

Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.

Root cause (FDA determination)

Other

Action the firm took

The Product Corrective Action Customer Letter which includes Modified Operating Instructions was sent to US and Canadian customers the week of November 8, 2004 via US Mail.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2004-11-02

Posted by FDA

2004-11-30

Terminated

2012-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35835. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.