FDAJune 18, 2024device
FoundationOne Companion Diagnostic (F1CDx)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
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)2025-04-09
- 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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