FDA Medical Device Recalls (openFDA)
Foundation Medicine, Inc.: FoundationOne Companion Diagnostic (F1CDx)
- Recall number
- Z-1891-2025
- Recalling firm
- Foundation Medicine, Inc.
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Status
- Open, Classified
- Initiated
- 2023-02-15
- Posted
- 2025-05-30
- Terminated
- not on file
- Reason
- An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
- Root cause
- Software design
- Action
- On February 15, 2023, the physician was alerted of the amended report within the physician's portal. Physician was informed original report included an incorrect negative CDx claim on the claims page; the CDx variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. It is requested that any impact to patient care be forwarded to Foundation Medicine.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of WI.
- Lot, serial or model codes
- Report Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.
- 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