FDA-Device2021-07-28Class II
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
Soft Computer Consultants, Inc.
Hazard
Software showing wrong results reported, PDF not match HIS.
Sold states
US Distribution to: CA only
Affected count
1
Manufactured in
5400 Tech Data Dr, N/A, Clearwater, FL, United States
Products
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2093-2021Don't want to check this manually?
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