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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Product Description
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FDA Recall
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Z-0577-2026 - FoundationOne CDx (F1CDx), RAL-0003 version 31.0 2 11/21/2025 FEI # 3010679023
Foundation Medicine, Inc.
Z-0578-2026 - FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 2 11/21/2025 FEI # 3010679023
Foundation Medicine, Inc.
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