Recall Z-2421-2010
Abbott Laboratories · initiated April 5, 2010
Product
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
Codes / lots: List 08H00-01, 08H00-03, PCB Assembly part number 8960167101
Reason for recall
Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2421-2010
- Initiated
- April 5, 2010
- Posted by FDA
- September 14, 2010
- Terminated
- May 17, 2011
- Product code
- GKZ – Counter, Differential Cell
- 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.
- Recalling firm
- Abbott Laboratories, Santa Clara, CA