Company: Abbott Laboratories
Date of Enforcement Report 6/3/2009
Class:ll

PRODUCT
Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01. Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube mode that aspirates samples from open collection tubes. Recall # Z-1398-2009

REASON
Burn Risk– when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit). If the customer touches the motor, burns may occur.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter dated February 12, 2009. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
324 instruments

DISTRIBUTION
Nationwide and countries of Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela