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Foundation Medicine, Inc. recalls FoundationOne CDx test report
Recalled December 4, 2019 · FDA recall Z-0535-2020 · Foundation Medicine
Hazard
Identified potential false positive MSI-H on the test reports provided to the physicians. · FDA Class II
Units
8 reports
Sold at
MA, NC,IN, OH, GA
Description
Identified potential false positive MSI-H on the test reports provided to the physicians.
Product
FoundationOne CDx test report
Manufacturer(s)
Foundation Medicine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →