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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN Sapphire Hematology Analyzer

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  Class 2 Device Recall CELLDYN Sapphire Hematology Analyzer see related information
Date Initiated by Firm August 25, 2008
Date Posted November 21, 2008
Recall Status1 Terminated 3 on January 06, 2011
Recall Number Z-0306-2009
Recall Event ID 49397
510(K)Number K051215  
Product Classification Differential Cell Counter - Product Code GKZ
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.
Code Information 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
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact
408-982-4800
Manufacturer Reason
for Recall		 Exposed wire resulted in minor electrical shock and burn to the service technician
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 958 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = ABBOTT LABORATORIES
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