FDA-Device2018-12-26Class II
FoundationOne CDx Test Results
Foundation Medicine, Inc.
Hazard
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
Sold states
US nationwide
Affected count
800 reports
Manufactured in
150 2nd St, Cambridge, MA, United States
Products
FoundationOne CDx Test Results
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0649-2019Don't want to check this manually?
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