Z-1891-2025Class II

FoundationOne Companion Diagnostic (F1CDx)

Name: Z-1891-2025 FoundationOne Companion Diagnostic (F1CDx)
Creator: Foundation Medicine, Inc.
Published: 2023-02-15
License: https://open.fda.gov/license/

Foundation Medicine, Inc. / initiated 2023-02-15 / Open, Classified / root cause: software

FDA source

Foundation Medicine, Inc. began a recall of FoundationOne Companion Diagnostic (F1CDx) on 2023-02-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1891-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-15
Posted: 2025-05-30
Recalling firm: Foundation Medicine, Inc.
Product: FoundationOne Companion Diagnostic (F1CDx)
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: 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 tag: software
FDA 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 in commerce: 1 unit
Distribution: US Nationwide distribution in the state of WI.
Product codes and lots: Report Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1891-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1891-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30

Product code PQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)