Foundation Medicine Recalls

2 recalls found for Foundation Medicine. Check if any of your products are affected.

HIGHFDA DEVICE

Foundation Medicine Recalls Companion Diagnostic Over Missing Claims Page

Foundation Medicine recalled 59 units of its FoundationOne CDx (F1CDx), RAL-0003 version 31.0 on November 8, 2022. The recall affects devices distributed in the U.S. and internationally due to missing important diagnostic information. Patients and healthcare providers must stop using the device immediately and follow manufacturer instructions.

Foundation Medicine
Reports were
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Brand Statistics

Total Recalls
2
Pages
1