Company: Soft Computer Consultants, Inc.
Date of Enforcement Report 2/1/2017
Class lI:
PRODUCT
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.
Recall Number Z-1097-2017
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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