Foundation Medicine, Inc. recalls FoundationOne CDx test report
- Recall date
- August 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0535-2020
- FDA classification
- Class II
- Brand / firm
- Foundation Medicine, Inc.
- Sold / distributed
- MA, NC,IN, OH, GA
Why it was recalled
Identified potential false positive MSI-H on the test reports provided to the physicians.
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 report
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