FDAMay 20, 2014device

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

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

The hazard

The interface fails to send abnormal flags for Reference Lab test results.

What to do

FDA enforcement status: Terminated

Brands named

scc soft computersccscc soft

Recall history

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

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