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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 20, 2002
Date Posted January 30, 2003
Recall Status1 Terminated 3 on April 23, 2004
Recall Number Z-0492-03
Recall Event ID 25382
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory version 5.3
Code Information Version 5.3
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark Ellis
520-570-2000
Manufacturer Reason
for Recall		 Software anomally. English text code does not translate.
FDA Determined
Cause 2		 Other
Action Recall notice was sent by fax on 12/20/2002.
Quantity in Commerce 26
Distribution Nationwide. NO international or government accounts.
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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