Foundation Medicine recalled 18 units of the FoundationOne Liquid CDx (F1LCDx) on November 8, 2022. Reports sent to customers lacked the necessary companion diagnostic Claims Page. The issue affects customers across multiple U.S. states and in Japan and Singapore.
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 recall involves FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0. It was distributed nationwide in the U.S. and internationally to Japan and Singapore. The product was sold in a total of 18 units.
The recall is due to reports sent to customers that did not include the companion diagnostic Claims Page. This could lead to potential misinterpretation of test results, posing a high risk to patient safety.
As of now, there are no reported injuries or adverse events associated with this issue. The recall was initiated to prevent any potential harm to patients.
Patients and healthcare providers should stop using the product immediately. Follow the recall instructions sent by the manufacturer and contact Foundation Medicine for further information.
For further assistance, contact Foundation Medicine at the number provided in the recall notification. More details can be found at the FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0578-2026.
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