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U.S. Department of Health and Human Services

Class 2 Device Recall Misys Laboratory

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  Class 2 Device Recall Misys Laboratory see related information
Date Initiated by Firm October 18, 2002
Date Posted December 05, 2002
Recall Status1 Terminated 3 on December 01, 2004
Recall Number Z-0324-03
Recall Event ID 25010
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory versions 5.23 and 5.3 with Callback
Code Information Versions 5.23 and 5.3 with Callback.
Recalling Firm/
Manufacturer		 Sunquest Information Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark S. Ellis
520-570-2000
Manufacturer Reason
for Recall		 Software anomally - animal ranges, when desired on reports, are defaulting to human male ranges.
FDA Determined
Cause 2		 Other
Action Notice of recall was sent by fax on October 18, 2002. A software fix will be available for version 5.3 in January 2003. Users will be notified again of this new release and be urged to update from version 5.23 to version 5.3. Completion of the recall is estimated to be in March 2003.
Quantity in Commerce 463
Distribution Nationwide and to the United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, and 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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