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Z-0578-2026Class II

Foundation Medicine, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Foundation Medicine, Inc.
Product type
Device
Status
Ongoing
Report date
2025-12-03
Distribution
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.
Firm state
MA
Product quantity
18 units (17 US, 1 OUS)
Initiated by
Voluntary: Firm initiated
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.

Product description

FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

Code / lot info

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),

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →