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Foundation Medicine Recalls

3 recalls found for Foundation Medicine. Check current safety alerts and related brands before using affected products.

Active recalls: 3
Pages: 1

HIGH

FDA DEVICE

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989,...

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

Mar 24, 2026

Foundation Medicine

Potential for

Health & Personal Care

HIGH

FDA DEVICE

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

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.

Nov 8, 2022

Foundation Medicine

Reports were

Health & Personal Care

HIGH

FDA DEVICE

Foundation Medicine FoundationOne CDx Recalled for Missing Companion Diagnostic Claims Page

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.

Nov 8, 2022

Foundation Medicine

Reports were

Brand Statistics

Total Recalls

Pages

Foundation Medicine Recalls

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989,...

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

Foundation Medicine FoundationOne CDx Recalled for Missing Companion Diagnostic Claims Page

Brand Statistics

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