Cl II SoftLab with SA HIS

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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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.