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Medical Device Notification
Misys Laboratory Blood Bank Module, Version 6.1

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DATE NOTIFICATION INITIATED:

    March 15, 2006

PRODUCT:

    Misys Laboratory Blood Bank Module, Version 6.1

MANUFACTURER:

    Misys Healthcare Systems
    Tucson, Arizona

REASON:

    Misys Healthcare Systems issued a “Product Safety Notice” (PSN-06-01).

    Blood bank computer software contains a defect that could cause the data being entered to be out of sync with the accession number, patient and/or unit(s) displayed on the screen. The defect 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 April 7, 2006
 
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