FDAMarch 31, 2021device

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 perfor...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Software showing wrong results reported, PDF not match HIS.

What to do

FDA enforcement status: Terminated

Brands named

soft computer consultantssoftsoft computer

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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