CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells.
- Company
- Abbott Laboratories
- Recall Initiated
- August 25, 2008
- Posted
- November 21, 2008
- Terminated
- January 6, 2011
- Recall Number
- Z-0306-2009
- Quantity
- 958 units
- Firm Location
- Santa Clara, CA
Reason for Recall
Exposed wire resulted in minor electrical shock and burn to the service technician
Distribution
Worldwide Distribution --- including USA and countries of Argentina, Australia, Brazil, Canada, Chile, China WFOTC, Colombia, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela.
Lot / Code Info
All pre production units with Serial numbers S-001 to S-026 and all production units with serial numbers 42003AZ-42007AZ, 42010AZ-42030AZ, 42032AZ-42033AZ, 42037AZ-42059AZ, 42061AZ-42062AZ, 42064AZ-42067AZ, 42072AZ-42074AZ, 42076AZ-42081AZ, 42083AZ-42123AZ, 42125AZ-42852AZ, 42854AZ-42944AZ, 42946AZ-42949AZ, 42951AZ, 42953AZ, 42955AZ-42961AZ, and 42963AZ-42964AZ
Root Cause
Device Design
Action Taken
Recall issued August 22, 2008. Technical service bulletin was issued for all field personnel via internal database. No customer communication is planned as customers are instructed *not* to remove the cover, which is necessary to access the area.