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Medical Device Notification
Misys Laboratory Blood Bank and Blood Donor, Version 6.1

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DATE NOTIFICATION INITIATED:

    May 20, 2005

PRODUCT:

    Misys Laboratory Blood Bank and Blood Donor, Version 6.1

MANUFACTURER:

    Misys Healthcare System
    Tuscon, AZ

REASON:

    Misys Healthcare Systems issued a "Product Safety Notice" (PSN 05-03).

    Information entered into the comment field may be lost when resulting the blood type for the first time via a blood bank instrument interface. The software problem will be corrected with the installation of a software patch.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

Updated June 16, 2005
 
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