Class 1 Device Recall Mysis Laboratory

• Date Initiated by Firm: August 12, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on March 15, 2004
• Recall Number: Z-0007-04
• Recall Event ID: 27077
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Calculator/Data Processing Module for Clinical Use
• Code Information: Versions 5.2, 5.23, & 5.3
• FEI Number: 1000306472
• Recalling Firm/ Manufacturer: Misys Healthcare Systems; 4801 E Broadway Blvd; Tucson AZ 85711
• For Additional Information Contact: Dave Cox; 520-570-2000
• Manufacturer Reason for Recall: Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.
• FDA Determined Cause: Other
• Action: Product Safety Notice, PSN-03-L37 was issued to all affected clients by facsmile. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.
• Quantity in Commerce: 479
• Distribution: Nationwide, UK, Ireland, Canada, Denmark, United Arab Emirates & Bermuda
• 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.