Device product
FoundationOne CDx test report
Z-0535-2020
Product summary
- Event
- Event 83729
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 reports
- Official record key
device-enforcement:Z-0535-2020
Official wording
Reason: Identified potential false positive MSI-H on the test reports provided to the physicians.
Code information: Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01
Distribution pattern: MA, NC,IN, OH, GA
Derived failure modes
-
Unknown
Identified potential false positive MSI-H on the test reports provided to the physicians.