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FDAOctober 31, 2018device

FoundationOne CDx Test Results

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

The hazard

An incorrect test result for a single analyte may have been reported for up to 800 physician reports

What to do

FDA enforcement status: Terminated

Brands named

foundation medicinefoundation

Recall history

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

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