Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagnostics Division, Santa Clara, CA. 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

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.

A "Product Correction" letter dated February 12, 2009 and "Customer Reply" form were sent to all currently active CELL-DYN Ruby customers using Software Version 2.0 ML. The letter described the affected product, necessary actions and contact information for customers. Customers were instructed to acknowledge receipt of the "Product Correction" letter by completing the enclosed Customer Reply form and return via fax to 1-800-777-0051. A product information letter is being added to the accessory kits shipped with new instruments and version 2.0 ML System Software upgrade kits. For questions regarding this information, contact Abbott Laboratories Customer Support by calling 1-877-422-2688. Customers outside the US, please contact your local hematology customer support representative.