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Foundation Medicine, Inc. recalls FoundationOne CDx Test Results
Recalled December 26, 2018 · FDA recall Z-0649-2019 · Foundation Medicine
Hazard
An incorrect test result for a single analyte may have been reported for up to 800 physician reports · FDA Class II
Units
800 reports
Sold at
US nationwide
Description
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
Product
FoundationOne CDx Test Results
Manufacturer(s)
Foundation Medicine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →