Foundation Medicine, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0578-2026)

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 Liquid CDx (F1LCDx), TECH-0009 version 6.0

Product Classification:

Class II

Date Initiated: November 8, 2022

Date Posted: December 3, 2025

Recall Number: Z-0578-2026

Event ID: 97854

Reason for Recall:

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

Status: Ongoing

Product Quantity: 18 units (17 US, 1 OUS)

Code Information:

F1LCDx - TECH-0009 version 6.0; Test Numbers: ORD-XXX6703-01 (JP), ORD-XXXX411-01 (US), ORD-XXXX128-01 (US), ORD-XXXX061-01 (US), ORD-XXXX270-01 (US), ORD-XXXXX94-01 (US), ORD-XXXX058-01 (US), ORD-XXXX099-01 (US), ORD-XXXX089-01 (US), ORD-XXXX252-01 (US), ORD-XXXX640-01 (US), ORD-XXX5300-01 (US), ORD-XXXX453-01 (US), ORD-XXXX101-01 (US), ORD-XXXX070-01 (US), ORD-XXXX231-01 (US), ORD-XXXX496-01 (US), ORD-XXXX202-01 (US),

Distribution Pattern:

US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated