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U.S. Department of Health and Human Services

Class 2 Device Recall Misys Laboratory

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 Class 2 Device Recall Misys Laboratorysee related information
Date Initiated by FirmOctober 18, 2002
Date PostedMarch 13, 2003
Recall Status1 Terminated 3 on December 03, 2004
Recall NumberZ-0647-03
Recall Event ID 25009
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductMisys Laboratory, version 5.3 with Reference Laboratory Interface
Code Information Version 5.3 with Reference Laboratory Interface
FEI Number 1000306472
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 anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface.
FDA Determined
Cause 2		Other
ActionA product workaround was communicated to the two affected sites by facsimile on October 18, 2002. The recall is complete.
Quantity in Commerce2
DistributionStates of WI, and IL.
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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