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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 October 28, 2002
Date Posted December 05, 2002
Recall Status1 Terminated 3 on December 01, 2004
Recall Number Z-0319-03
Recall Event ID 25074
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Misys Laboratory version 5.2 with Results Interface 14
Code Information Version 5.2 with Results Interface 14
Recalling Firm/
Manufacturer
Sunquest Information Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information Contact Mark S. Ellis
520-382-6219
Manufacturer Reason
for Recall
Software coding error caused data formatting error.
FDA Determined
Cause 2
Other
Action The coding error was detected in one of two sister hospitals using like systems. The defect was corrected August 16, 2002.
Quantity in Commerce 2
Distribution State of New York.
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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