Foundation Medicine issued a recall affecting 18 FoundationOne Liquid CDx tests, including 17 in the United States and 1 overseas. The defect is the absence of the companion diagnostic CDx Claims Page in reports. Amended claims pages were distributed within seven days. Stop use immediately and follow manufacturer instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Foundation Medicine, Inc. or your healthcare provider for instructions. Notification method: Letter
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FoundationOne Liquid CDx is a liquid biopsy tumor profiling test used to identify genomic alterations for cancer treatment decisions.
The defect is the absence of the CDx Claims Page in reports, which could affect the completeness of diagnostic information presented to clinicians.
This recall is not described as part of a broader industry pattern.
Clinicians may rely on incomplete reports, potentially influencing treatment decisions.
Look for ORD-XXXX-XX identifiers on the report or accompanying documentation.
Remedies typically follow a recall process via manufacturer, with refunds/replacements coordinated within weeks.
Maintain copies of the recall notice, ORD numbers, and all correspondence with the manufacturer.
Product: FoundationOne Liquid CDx (F1LCDx) TECH-0009 version 6.0. Quantity: 18 units (17 US, 1 OUS). Distribution: US nationwide in states including 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 Japan and Singapore. Model numbers include F1LCDx - TECH-0009 version 6.0 and ORD numbers such as 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-XX
No injuries or incidents have been reported.
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