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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmOctober 28, 2002
Date PostedDecember 05, 2002
Recall Status1 Terminated 3 on December 01, 2004
Recall NumberZ-0319-03
Recall Event ID 25074
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMisys 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 ContactMark S. Ellis
520-382-6219
Manufacturer Reason
for Recall		Software coding error caused data formatting error.
FDA Determined
Cause 2		Other
ActionThe coding error was detected in one of two sister hospitals using like systems. The defect was corrected August 16, 2002.
Quantity in Commerce2
DistributionState of New York.
Total Product Life CycleTPLC 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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