Class 2 Device Recall

• Date Initiated by Firm: May 13, 2005
• Date Posted: June 28, 2005
• Recall Status: Terminated on February 10, 2006
• Recall Number: Z-0938-05
• Recall Event ID: 32174
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Misys Laboratory with Lab Access Results application for versions 5.3 and later.
• Code Information: Versions 5.3 and later.
• FEI Number: 1000306472
• Recalling Firm/ Manufacturer: Misys Healthcare Systems; 4801 E Broadway Blvd; Tucson AZ 85711-3609
• For Additional Information Contact: Tom Goelz; 520-570-2408
• Manufacturer Reason for Recall: Software anomaly may rarely allow modification of previously reported specimen results.
• FDA Determined Cause: Other
• Action: Product Safety Notice PSN-05-01 was sent by fax on May 13, 2005 and includes a procedural work-around to avoid the defect until the firm is able to provide a software patch.
• Quantity in Commerce: 258
• Distribution: Nationwide and United Kingdom, Ireland, Denmark, Canada, 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.