Foundation Medicine, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1747-2025)

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: April 9, 2025

Date Posted: May 21, 2025

Recall Number: Z-1747-2025

Event ID: 96621

Reason for Recall:

Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.

Status: Ongoing

Product Quantity: 4 units

Code Information:

ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.

Voluntary or Mandated:

Voluntary: Firm initiated