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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 15, 2002
Date Posted January 11, 2003
Recall Status1 Terminated 3 on June 01, 2004
Recall Number Z-0422-03
Recall Event ID 25162
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory version 5.3
Code Information Version 5.3
Recalling Firm/
Manufacturer		 Sunquest Information Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
520-570-2000
Manufacturer Reason
for Recall		 Software development logic defect.
FDA Determined
Cause 2		 Other
Action Notice of the recall was sent to customers by fax on 11/15/2002.
Quantity in Commerce 461
Distribution Nationwide and to United Kingdom, Canada, Ireland, Denmark, Bermuda, Saudi Arabia, United Arab Emirates.
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.
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