—#43332

Product

Cytomics FC500 with CXP Software

FDA product code: JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Part Numbers 629636 629637

Why it was recalled

Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0

Root cause (FDA determination)

Software change control

Action the firm took

A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2005-11-23
Posted by FDA: 2006-01-11
Terminated: 2012-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43332. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.