FDAApril 9, 2025device
FoundationOne Companion Diagnostic (F1CDx)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
What to do
FDA enforcement status: Ongoing
Brands named
foundation medicinefoundation
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAProtocol 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, 01990, 01994, 01995.2026-03-24
- FDASequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)2026-03-20
- CPSCProfessional's Choice Sports Medicine Products Recalls Equine Bits Due to Fall Hazard2025-06-26
- FDABostonSight SCLERAL Lens2025-06-10
- FDABostonSight PROSE Lens.2025-06-10
- FDAFoundationOne Companion Diagnostic (F1CDx)2024-06-18
- FDAAFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)2023-12-22
- FDAAFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)2023-12-22
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