FDA-Device2019-12-04Class II
FoundationOne CDx test report
Foundation Medicine, Inc.
Hazard
Identified potential false positive MSI-H on the test reports provided to the physicians.
Sold states
MA, NC,IN, OH, GA
Affected count
8 reports
Manufactured in
150 2nd St, Cambridge, MA, United States
Products
FoundationOne CDx test report
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2020Don't want to check this manually?
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