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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 December 06, 2002
Date Posted January 30, 2003
Recall Status1 Terminated 3 on February 26, 2013
Recall Number Z-0497-03
Recall Event ID 25238
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Reference Library Interface Version 5.3
Code Information Version 5.3
Recalling Firm/
Sunquest Information Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
Manufacturer Reason
for Recall
Software system defect resulting in incomplete patient results information.
FDA Determined
Cause 2
Action Product Safety Notice, PSN-02-L31 will be faxed to all affected customers. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.
Quantity in Commerce 30
Distribution Nationwide
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.