Foundation Medicine, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1890-2025)

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: June 18, 2024

Date Posted: June 11, 2025

Recall Number: Z-1890-2025

Event ID: 96802

Reason for Recall:

Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.

Status: Ongoing

Product Quantity: 2 units

Code Information:

Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.

Distribution Pattern:

US Nationwide distribution in the state of MI.

Voluntary or Mandated:

Voluntary: Firm initiated