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U.S. Department of Health and Human Services

Class 2 Device Recall Mysis Commercial Laboratory

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 Class 2 Device Recall Mysis Commercial Laboratorysee related information
Date Initiated by FirmJuly 24, 2003
Date PostedSeptember 11, 2003
Recall Status1 Terminated 3 on April 23, 2004
Recall NumberZ-1220-03
Recall Event ID 27030
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductCalculator/ Data Processing Module for Clinical Use
Code Information Version 3.x
FEI Number 1000306472
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
For Additional Information ContactBarbara Brown
520-733-6403
Manufacturer Reason
for Recall		Software Design Defect. Under certain conditions, results are removed.
FDA Determined
Cause 2		Other
ActionPublic Safety Notice was issued to all all affected clients by facsmile on 7/24/2003.
Quantity in Commerce47
DistributionNationwide
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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