Company: Soft Computer Consultants, Inc.
Date of Enforcement Report 2/1/2017
Class lI:
PRODUCT
Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation..
Recall Number Z-1098-2017
REASON
Software error. Potential for incorrect results
RECALLING FIRM/MANUFACTURER
Soft Computer Consultants, Inc., Clearwater, FL on 10/6/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
189
DISTRIBUTION
Nationwide and Internationally
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