Class 2 Device Recall

• Date Initiated by Firm: June 16, 2003
• Date Posted: August 07, 2003
• Recall Status: Terminated on April 23, 2004
• Recall Number: Z-1090-03
• Recall Event ID: 26678
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module
• Code Information: Version 5.3 and up to 5.3.2 with Anatomic Pathology Module.
• 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 anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.
• FDA Determined Cause: Other
• Action: The firm sent a fax of Product Safety Notice PSN-03-L28 to customers on June 16, 2003 which contained a procedural workaround. Once the corrective software is released a second notice will be made to affected customers. Proposed recall completion date is 9/15/2003.
• Quantity in Commerce: 315
• Distribution: Nationwide and to UK, Ireland, Canada, Bermuda, Saudi Arabia.
• 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.