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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 24, 2002
Date PostedDecember 11, 2002
Recall Status1 Terminated 3 on February 26, 2013
Recall NumberZ-0325-03
Recall Event ID 25077
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMisys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus.
Code Information Versions 5.2, 5.23 and 5.3 with ADT Interface to CoPathPlus.
Recalling Firm/
Manufacturer		 Sunquest Information Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information ContactMark Ellis
520-570-2000
Manufacturer Reason
for Recall		Interfacing software systems have inconsistent character recognition characteristics.
FDA Determined
Cause 2		Other
ActionA recall notice was sent to hospitals on October 24, 2002. It communicated a temporary procedure to work around the problem. Also mentioned was the availabllity of a utility to detect and report suspected duplicate Medical Record Numbers.
Quantity in Commerce190
DistributionNationwide and to Denmark, Bermuda, United Kingdom, Saudi Arabia, Canada.
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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