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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmMarch 24, 2003
Date PostedMay 09, 2003
Recall Status1 Terminated 3 on April 14, 2004
Recall NumberZ-0806-03
Recall Event ID 26042
ProductMisys Commercial Laboratory, Laboratory Information System, version 3.4.1
Code Information Version 3.4.1
FEI Number 1000306472
Recalling Firm/
Manufacturer		 Misys Healthcare Systems
101 East Park Blvd
Plano TX 75074
For Additional Information ContactBarbara Browne
520-570-2000
Manufacturer Reason
for Recall		Software logic error.
FDA Determined
Cause 2		Other
ActionThe firm wrote and installed code to correct the problem on 3/13/2003. Recall is complete.
Quantity in Commerce1
DistributionOnly to one account in Chester, SC.
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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