Abbott CELL-DYN 3000 Hematology Analyzer
- Company
- Abbott Laboratories
- Recall Initiated
- May 11, 2007
- Posted
- August 29, 2007
- Terminated
- June 19, 2008
- Recall Number
- Z-1198-2007
- Quantity
- 3,429 units, all models
- Firm Location
- Santa Clara, CA
Reason for Recall
The product failed electrostatic discharge testing, which could result in product failure.
Distribution
Worldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kong, Jamaica, Japan, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.
Lot / Code Info
Model number CELL-DYN 3000 CS: List Numbers 91323-01 and 91323-03, all serial numbers distributed on or before May 3, 2007. Model number CELL-DYN 3000 SL: List Numbers 91325-01 and 91325-03; all serial numbers distributed on or before May 3, 2007.
Root Cause
Other
Action Taken
Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.