Recall Z-2421-2010 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA
| Date | Sep 14, 2010 (initiated Apr 5, 2010) |
| Status | Terminated |
| Reason | Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results. |
| Root cause | Other |
| Action | Abbott Diagnostics Division of Santa Clara, CA initiated a field correction of the CELL-DYN Sapphire Probe Detector Assembly used on the CELL-DYN Sapphire Hemotology Analyzer, on April 5, 2010. The correction is being addressed through field service representatives and a mandatory Technical Service Bulletin (TSB). The TSB requires inspection, testing, and potential replacement of the affected assembly. The firm will not be issuing a seperate notification. For questions regarding this correction please contact (408) 982-4800, or fax (408) 982-4863. |
| Quantity | 926 units |
| Distribution | Product was distributed to 926 retailers throughout the US and to argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong King, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051215 | CELL-DYN SAPPHIRE SYSTEM Abbott Laboratories, Jul 21, 2005 |