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.ġ A record in this database is created when a firm initiates a correction or removal action. No customer communication is planned as customers are instructed *not* to remove the cover, which is necessary to access the area. ![]() Technical service bulletin was issued for all field personnel via internal database. Class 2 Device Recall CELLDYN Sapphire Hematology Analyzerĭifferential Cell Counter - Product Code GKZĬELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03Ī multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells.Īll 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-42964AZĮxposed wire resulted in minor electrical shock and burn to the service technician
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