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
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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
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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 |
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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
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