Class 2 Device Recall

• Date Initiated by Firm: January 31, 2003
• Date Posted: March 06, 2003
• Recall Status: Terminated 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/ Manufacturer: Misys Healthcare Systems; 4801 E Broadway Blvd; Tucson AZ 85711
• For Additional Information Contact: Mark Ellis; 520-570-2000
• Manufacturer Reason for Recall: Software anomaly. Patient results may be filed in the incorrect patient file
• FDA Determined Cause: Other
• 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.