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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 June 10, 2003
Date Posted July 15, 2003
Recall Status1 Terminated 3 on April 23, 2004
Recall Number Z-1007-03
Recall Event ID 26541
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 Barbara Brown
Manufacturer Reason
for Recall
Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations.
FDA Determined
Cause 2
Action Notification was sent by fax under Product Safety Notice, PSN-03-L27 on June 10, 2003 also under PSN-03-L27 on June 13, 2003 to sites with MIM functionality.
Quantity in Commerce 467
Distribution Nationwide and to Ireland, Canada, Denmark, Bermuda, UK, 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.