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Class 2 Device Recall CELLDYN Sapphire Hematology Analyzer |
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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
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Product Classification |
Differential Cell Counter - Product Code GKZ
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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
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For Additional Information Contact |
408-982-4800
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Manufacturer Reason for Recall |
Exposed wire resulted in minor electrical shock and burn to the service technician
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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
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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.
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510(K) Database |
510(K)s with Product Code = GKZ and Original Applicant = ABBOTT LABORATORIES
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