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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 April 05, 2010
Date Posted September 14, 2010
Recall Status1 Terminated 3 on May 17, 2011
Recall Number Z-2421-2010
Recall Event ID 56422
510(K)Number K051215  
Product Classification Counter, Differential Cell - Product Code GKZ
Product CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA
Code Information List 08H00-01, 08H00-03, PCB Assembly part number 8960167101
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		 Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.
FDA Determined
Cause 2		 Other
Action Abbott Diagnostics Division of Santa Clara, CA initiated a field correction of the CELL-DYN Sapphire Probe Detector Assembly used on the CELL-DYN Sapphire Hemotology Analyzer, on April 5, 2010. The correction is being addressed through field service representatives and a mandatory Technical Service Bulletin (TSB). The TSB requires inspection, testing, and potential replacement of the affected assembly. The firm will not be issuing a seperate notification. For questions regarding this correction please contact (408) 982-4800, or fax (408) 982-4863.
Quantity in Commerce 926 units
Distribution Product was distributed to 926 retailers throughout the US and to argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong King, 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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