Company: SCC Soft Computer
Date of Enforcement Report:5/21/2014
Class lI:
PRODUCT
SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.
Recall Number Z-1573-2014
REASON
When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL on 4/29/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
IL
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