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FDANovember 8, 2022device

FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

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

The hazard

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

What to do

FDA enforcement status: Ongoing

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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