Recall Z-1199-2007 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Abbott CELL-DYN 3500 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 |
510(k) clearances named in this recall
| K913305 | CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER Unipath , Ltd., Nov 22, 1991 |
| K955715 | CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) Abbott Laboratories, Oct 8, 1996 |
| K960427 | ABBOTT CELL-DYN 3500R SYSTEM Sequoia Turner Corp., May 2, 1996 |
| K980614 | ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS Abbott Laboratories, Apr 24, 1998 |
| K991605 | CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION Abbott Laboratories, Jul 9, 1999 |