Recall Z-1198-2007
Abbott Laboratories · initiated May 11, 2007
Product
Abbott CELL-DYN 3000 Hematology Analyzer
Codes / lots: 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.
Reason for recall
The product failed electrostatic discharge testing, which could result in product failure.
FDA-determined 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.
Details
- Recall number
- Z-1198-2007
- Initiated
- May 11, 2007
- Posted by FDA
- August 29, 2007
- Terminated
- June 19, 2008
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 3,429 units, all models
- 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.
- Recalling firm
- Abbott Laboratories, Santa Clara, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1199-2007 | Abbott CELL-DYN 3500 Hematology AnalyzerThe product failed electrostatic discharge testing, which could result in product failure. | 05/11/2007Terminated |
| Z-1200-2007 | Abbott CELL-DYN 3700 Hematology AnalyzerThe product failed electrostatic discharge testing, which could result in product failure. | 05/11/2007Terminated |