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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDyn Ruby Hematology Analyzer

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  Class 2 Device Recall CELLDyn Ruby Hematology Analyzer see related information
Date Initiated by Firm November 17, 2008
Date Posted April 10, 2009
Recall Status1 Terminated 3 on November 27, 2010
Recall Number Z-1064-2009
Recall Event ID 50478
510(K)Number K061667  
Product Classification Differential Cell Counter - Product Code GKZ
Product CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01

The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes.
Code Information Serial No. 34001BG - 34965BG
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact
877-422-2688
Manufacturer Reason
for Recall		 Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.
FDA Determined
Cause 2		 Other
Action Recall initiated on 11/17/2008. A Product Correction letter and customer reply form is sent to all currently active CELL-DYN Ruby customers. The customers are asked to keep the communication with their CELL-DYN Ruby System Operator's Manual and to note that the information listed in the table replaces the carryover specification provided in all applications of the manual. Questions from customers in the US should be directed to Customer Support at 1-877-4ABBOTT. Customers outside the US should contact their local hematology customer support representative.
Quantity in Commerce 899 units
Distribution Worldwide Distribution
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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