Soft Computer Consultants, Inc. recalls SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a c…
- Recall date
- March 31, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2093-2021
- FDA classification
- Class II
- Brand / firm
- Soft Computer Consultants, Inc.
- Sold / distributed
- US Distribution to: CA only
Why it was recalled
Software showing wrong results reported, PDF not match HIS.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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