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Recall of Blood Bank Data Management System Software
Soft Computer Consultants, Inc.

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DATE RECALL INITIATED:

March 21, 2003

PRODUCT / VERSIONS:

Softbank II Laboratory Information System, V.19, V.21, and V.22, Release 3.1.3

MANUFACTURER:

Soft Computer Consultants, Inc.
Palm Harbor, FL

REASON:

Soft Computer Consultant's "Softbank II" laboratory information system software will attach blood bank test results, specifically ABO/Rh, to an incorrect patient record. The firm's follow-up determined that the root cause of the error was an anomaly in the software that allowed two identical interfaces to run concurrently. The software problem was 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 February 20, 2004
 
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