Reported Dec 3, 2025 · Ongoing
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Foundation Medicine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Foundation Medicine, Inc. · 150 2nd St · Cambridge, MA · 02141-2115
Is this the product you have?
FoundationOne CDx (F1CDx)RAL-0003 version 31.0
- Lot codes and dates
- F1CDX - RAL-0003 version 31.0
- Test Numbers
ORD-XXXX425-01 (JP)ORD-XXX5703-01 (JP)ORD-XXXX467-01 (JP)ORD-XXXX474-01 (JP)ORD-XXXX460-01 (JP)ORD-XXXX612-01 (JP)ORD-XXXX484-01 (JP)ORD-XXXX440-01 (JP)ORD-XXXX665-01 (JP)ORD-XXXX699-01 (JP)ORD-XXXX546-01 (JP)ORD-XXXX689-01 (JP)ORD-XXXX695-01 (JP)ORD-XXXX451-01 (JP)ORD-XXXX455-01 (JP)ORD-XXXX476-01 (JP)ORD-XXXX481-01 (JP)ORD-XXXX477-01 (JP)ORD-XXXX509-01 (SG)ORD-XXXX511-01 (SG)ORD-XXXX985-01 (US)ORD-XXXX071-01 (US)ORD-XXXX731-01 (US)ORD-XXXX999-01 (US)ORD-XXXX069-01 (US)ORD-XXXX352-01 (US)ORD-XXXX993-01 (US)ORD-XXXX294-01 (US)ORD-XXXX822-01 (US)ORD-XXXX210-01 (US)ORD-XXXX683-01 (US)ORD-XXXX979-01 (US)ORD-XXXX413-01 (US)ORD-XXXX843-01 (US)ORD-XXXX316-01 (US)ORD-XXXX960-01 (US)ORD-XXXX001-01 (US)ORD-XXXX804-01 (US)ORD-XXXX600-01 (US)ORD-XXXX940-01 (US)ORD-XXXX367-01 (US)ORD-XXXX771-01 (US)ORD-XXXX169-01 (US)ORD-XXXX296-01 (US)ORD-XXXX290-01 (US)ORD-XXXX320-01 (US)ORD-XXXX255-01 (US)ORD-XXXX897-01 (US)ORD-XXXX377-01 (US)ORD-XXXX252-01 (US)ORD-XXXX475-01 (US)ORD-XXXX545-01 (US)ORD-XXXX690-01 (US)ORD-XXXX378-01 (US)ORD-XXXX740-01 (US)ORD-XXX1300-01 (US)ORD-XXXX470-01 (US)ORD-XXXX424-01 (US)ORD-XXXX115-01 (US)
- Amount recalled
- 59 units (39 US, 20 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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