Company:SCC Soft Computer
Date of Enforcement Report: 2/11/2015
Class lI:
PRODUCT
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
Recall Number Z-1038-2015
REASON
The interface fails to send abnormal flags for Reference Lab test results.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL on 5/202014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
28
DISTRIBUTION
Nationwide and Canada
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