Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Read the official notice →- Date
- 2025-06-11
- Country
- United States
- Brand
- Foundation Medicine
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Classification
- Class II
- Units
- US Nationwide distribution in the state of MI.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
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Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
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