FDA recall Z-0535-2020
Foundation Medicine, Inc. · Class II · device
Product
FoundationOne CDx test report
Reason for recall
Identified potential false positive MSI-H on the test reports provided to the physicians.
Distribution
MA, NC,IN, OH, GA
Key facts
- Status
- Terminated
- Initiation date
- 2019-08-08
- Report date
- 2019-12-04
- Termination date
- 2021-07-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Cambridge, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2020