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 Recall Z-0306-2009 · Posted 2008-11-21
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Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2008-08-25
Date Terminated2011-01-06
Product Quantity958 units
Reason for Recall
Exposed wire resulted in minor electrical shock and burn to the service technician
Firm Action
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.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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