FDAMay 31, 2017device

SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

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

The hazard

Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.

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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