Medical device recalls Moderate risk

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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