FoundationOne CDx test report
This recall has been terminated (originally issued August 8, 2019).
- Company
- Foundation Medicine, Inc.
- Recall Initiated
- August 8, 2019
- Terminated
- July 19, 2021
- Recall Number
- Z-0535-2020
- Quantity
- 8 reports
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Identified potential false positive MSI-H on the test reports provided to the physicians.
Distribution
MA, NC,IN, OH, GA
Lot / Code Info
Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01
Root Cause
Under Investigation by firm
Action Taken
Firm informed the physicians via phone stating: 1. They had recently received may have an incorrect MSI-H result which could be erroneous due to a possible false positive and to not use the MSI analyte to prescribe treatment. 2. The prescribing physicians were also told that an amended report designating MSI as undetermined would be issued immediately. 3. The physicians were asked if any treatment plan using the MSI result had been started and all confirmed that no treatment plan utilizing the MSI analyte had been used. 4. They were also informed of the availability of FMI Medical Affairs staff physicians to provide additional information or answer any follow questions that they may have.