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FDAAugust 8, 2019device

FoundationOne CDx test report

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

The hazard

Identified potential false positive MSI-H on the test reports provided to the physicians.

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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