Recall Z-1398-2009 ยท GKZ Counter, Differential Cell
Abbott Laboratories
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 mo
| Date | May 22, 2009 (initiated Feb 12, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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 question |
| Quantity | 324 units distributed |
| Distribution | Worldwide Distribution -- US, Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061667 | CELL-DYN RUBY SYSTEM Abbott Laboratories, Jul 10, 2006 |