FDA Medical Device Recalls (openFDA)
Foundation Medicine, Inc.: FoundationOne CDx test report
- Recall number
- Z-0535-2020
- Recalling firm
- Foundation Medicine, Inc.
- Product
- FoundationOne CDx test report
- Status
- Terminated
- Initiated
- 2019-08-08
- Posted
- not on file
- Terminated
- 2021-07-19
- Reason
- Identified potential false positive MSI-H on the test reports provided to the physicians.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 8 reports
- Distribution
- MA, NC,IN, OH, GA
- Lot, serial or model codes
- Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01
- 510(k) numbers
- not on file
- PMA numbers
- ["P170019"]
- Product code
- PQP
- Firm FEI
- 3010679023
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28