—#73250

Product

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.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K051215
Affected 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

Why it was recalled

Exposed wire resulted in minor electrical shock and burn to the service technician

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-08-25
Posted by FDA: 2008-11-21
Terminated: 2011-01-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73250. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.