Foundation Medicine recalled 59 units of FoundationOne CDx (F1CDx), RAL-0003 version 31.0 after reports indicated the companion diagnostic Claims Page was omitted. This oversight could impact patient care and healthcare provider decisions concerning diagnosis and treatment. Users should stop using the device and contact Foundation Medicine or their healthcare provider for further 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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The FoundationOne CDx is a genomic test that helps physicians make informed treatment decisions based on a patient's unique cancer profile. Patients typically use it to guide personalized therapy and improve treatment outcomes.
The absence of the companion diagnostic Claims Page in the reports could lead to a lack of essential information for healthcare providers when making diagnosis and treatment decisions.
This recall is not part of a broader industry pattern.
The recall may affect patients' access to personalized treatment plans, potentially delaying necessary care.
Look for the FoundationOne CDx model number on the test report provided to you by the healthcare provider.
Expect to receive a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
Keep a copy of the test report and all related communications with Foundation Medicine for your records.
Product: FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Quantity: 59 units (39 US, 20 OUS) Where Sold: Nationwide in the US and internationally, including Japan and Singapore Recall Date: November 8, 2022
No injuries or incidents have been reported.
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