Health & Personal Care Recalls

1,882 product recalls found in this category. Browse through all safety alerts and stay informed.

High Activity Category

This category has a significant number of recalls. Please check regularly for updates.

Health & Personal Care
HIGH
FDA DEVICE

Foundation Medicine FoundationOne Liquid CDx Recall 2022 Reminds Clinicians to Check CDx Pages (18 U

Foundation Medicine issued a recall affecting 18 FoundationOne Liquid CDx tests, including 17 in the United States and 1 overseas. The defect is the absence of the companion diagnostic CDx Claims Page in reports. Amended claims pages were distributed within seven days. Stop use immediately and follow manufacturer instructions.

Foundation Medicine
Reports were
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Health & Personal Care
HIGH
FDA DEVICE

Foundation Medicine FoundationOne CDx Recalled for Missing Companion Diagnostic Claims Page

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.

Foundation Medicine
Reports were
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Category Statistics

Total Recalls
1,882
Pages
95