Class 2 Device Recall

• Date Initiated by Firm: June 10, 2003
• Date Posted: July 15, 2003
• Recall Status: Terminated 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/ Manufacturer: Misys Healthcare Systems; 4801 E Broadway Blvd; Tucson AZ 85711
• For Additional Information Contact: Barbara Brown; 520-570-2000
• 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: Other
• 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.