Recall Z-0649-2019— Foundation Medicine, Inc.

Name: FDA recall Z-0649-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-31

Class II · Terminated

Class II FDA medical device recall by Foundation Medicine, Inc., initiated 2018-10-31, terminated 2020-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: FoundationOne CDx Test Results. Reason: An incorrect test result for a single analyte may have been reported for up to 800 physician reports.

Recalling firm: Foundation Medicine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-31
Terminated: 2020-04-17
Firm location: Cambridge, MA, United States

Product description

FoundationOne CDx Test Results

Reason for recall

An incorrect test result for a single analyte may have been reported for up to 800 physician reports

Data sourced from openFDA. This site is unofficial and independent of the FDA.