—#31732

Product

Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265

FDA product code: GKL — Counter, Cell, Automated (Particle Counter)
Device class: Class 2
Medical specialty: Hematology
Affected lot / code info: Version 1.0

Why it was recalled

Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.

Root cause (FDA determination)

Other

Action the firm took

Firm sent modified operating instructions to users on 13 February 2004.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2004-02-13
Posted by FDA: 2004-07-20
Terminated: 2012-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #31732. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.