Foundation Medicine, Inc. recalls FoundationOne CDx Test Results
- Recall date
- October 31, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0649-2019
- FDA classification
- Class II
- Brand / firm
- Foundation Medicine, Inc.
- Sold / distributed
- US nationwide
Why it was recalled
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
FoundationOne CDx Test Results
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