Class 2 Device Recall Misys Laboratory

• Date Initiated by Firm: October 18, 2002
• Date Posted: December 05, 2002
• Recall Status: Terminated 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: 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.