Foundation Medicine, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1891-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

FoundationOne Companion Diagnostic (F1CDx)

Product Classification:

Class II

Date Initiated: February 15, 2023

Date Posted: June 11, 2025

Recall Number: Z-1891-2025

Event ID: 96804

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.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

Report Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.

Distribution Pattern:

US Nationwide distribution in the state of WI.

Voluntary or Mandated:

Voluntary: Firm initiated