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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 January 31, 2003
Date Posted March 06, 2003
Recall Status1 Terminated 3 on July 14, 2004
Recall Number Z-0626-03
Recall Event ID 25557
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory System versions 5.2, 5.23 and 5.3
Code Information Versions 5.2, 5.23 and 5.3
Recalling Firm/
Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
Manufacturer Reason
for Recall
Software anomaly. Patient results may be filed in the incorrect patient file
FDA Determined
Cause 2
Action Notice of the correction was made by Fax on 1/31/2003. The notice indicated a procedural workaround to prevent the occurance of the defect. Corrections will be made to the software at only affected sites. These have been instructed to contact Applications Interface to schedule correction of the interface.
Quantity in Commerce 542
Distribution Nationwide and to United Kingdom, Ireland, Belgium, Canada, 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.