Foundation Medicine, Inc. is recalling 77 FoundationOne CDx and FoundationOne Liquid CDx diagnostic reports because they were issued without the required companion diagnostic (CDx) claims page. This missing information was corrected via amended reports distributed within 7 days of the error. No injuries or incidents have been reported in connection with this issue.
The absence of the claims page means that specific diagnostic results and related drug treatment recommendations may not have been fully communicated to healthcare providers, which could potentially impact treatment decisions for patients.
59 units (39 US, 20 OUS)
18 units (17 US, 1 OUS)
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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