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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 March 13, 2003
Recall Status1 Terminated 3 on December 03, 2004
Recall Number Z-0647-03
Recall Event ID 25009
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory, version 5.3 with Reference Laboratory Interface
Code Information Version 5.3 with Reference Laboratory Interface
Recalling Firm/
Sunquest Information Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark S. Ellis
Manufacturer Reason
for Recall
Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface.
FDA Determined
Cause 2
Action A product workaround was communicated to the two affected sites by facsimile on October 18, 2002. The recall is complete.
Quantity in Commerce 2
Distribution States of WI, and IL.
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.