Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagn
FDA device recall Z-1398-2009 · posted 2009-05-22 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 324 units distributed
- Distribution
- Worldwide Distribution -- US, Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela.
- Date initiated
- 2009-02-12
- Date posted
- 2009-05-22
- Date terminated
- 2010-12-27
- Location
- Santa Clara, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN RUBY SYSTEM (K061667) | Abbott Laboratories | 2006-07-10 |