Recall Z-1198-2007 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Abbott CELL-DYN 3000 Hematology Analyzer
| Date | Aug 29, 2007 (initiated May 11, 2007) |
| Status | Terminated |
| Reason | The product failed electrostatic discharge testing, which could result in product failure. |
| Root cause | Other |
| Action | 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. |
| 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, Ur |
| FDA record | Open on fda.gov |