Recall of Blood Bank Software

DATE RECALL INITIATED:

September 13, 2001

PRODUCT / LOT NUMBER

SAFETRACE TX, versions 1.2, 2.0.0, 2.1.0

MANUFACTURER:

Global Med Technologies, Inc.
Wyndgate Technologies Division
El Dorado Hills, CA

REASON:

Sotware performance tests conducted by the manufacture found that under certain circumstances, compatibility test results may be posted to another patient’s record. A workaround was provided in a “Product Safety Advisory” and a software change will be available in the next SafeTrace release.

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.