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.
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 recalled product is FoundationOne CDx (F1CDx), RAL-0003 version 31.0. It consists of 59 units, with 39 distributed in the United States and 20 internationally to Japan and Singapore. The product was not assigned a retail price.
The recall stems from reports sent to customers without the necessary companion diagnostic Claims Page. This oversight could hinder proper patient diagnosis and treatment.
There are no reported injuries or deaths associated with this recall. The issue relates solely to documentation rather than device malfunction.
Patients and healthcare providers must cease using the product immediately. Contact Foundation Medicine, Inc. or your healthcare provider for guidance and follow any instructions provided by the manufacturer.
For more information, visit the Foundation Medicine website or the FDA recall page. You can also contact Foundation Medicine directly for assistance.
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