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U.S. Department of Health and Human Services

Class 2 Device Recall Mysis Laboratory

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  Class 2 Device Recall Mysis Laboratory see related information
Date Initiated by Firm July 23, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on April 23, 2004
Recall Number Z-1240-03
Recall Event ID 27039
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Calculator/ Data Processing Module for Clinical Use
Code Information Verison 5.3 through 5.3.2
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact David C Cox
520-570-2000
Manufacturer Reason
for Recall		 Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report.
FDA Determined
Cause 2		 Other
Action Notification to all affected customers was sent by fax on 07/23/03 under PSN-03-L35, with the problem description, effective workaround and estimated release of coding modifications to the software version impacted.
Quantity in Commerce 466
Distribution Nationwide
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.
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