FoundationOne CDx (F1CDx), RAL-0003 version 31.0
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.
From the FDA notice · Read the official notice ↗ · All Foundation Medicine recalls
What to do
The agency's notice has the remedy and who to contact.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- FoundationOne CDx (F1CDx), RAL-0003 version 31.0
- Sold in
- Nationwide
- Made for
- Adults (18 years to 120 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- 59 units (39 US, 20 OUS)
- Illnesses reported
- None reported
- Manufactured in
- 150 2nd St, N/A, Cambridge, MA, United States
- Classification
- Class II
- Recall number
- Z-0577-2026
In the FDA's words
- Description
- FoundationOne CDx (F1CDx), RAL-0003 version 31.0 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. 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), Distribution: US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore. Affected quantity: 59 units (39 US, 20 OUS)
- Hazard
- 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.
2 products in this recall
Foundation Medicine FoundationOne CDx tests recalled for missing claims pages
Foundation Medicine sent some test reports to customers without the companion diagnostic (CDx) Claims Page. The missing pages were sent later in amended reports, within 7 days of the issue. This recall covers 2 products, FoundationOne CDx and FoundationOne Liquid CDx, with 77 affected units total.
The agency lists each product separately. Check every one you might have.
- FoundationOne CDx (F1CDx), RAL-0003 version 31.0 (this page)Z-0577-2026 · 59 units (39 US, 20 OUS)
- FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0Z-0578-2026 · 18 units (17 US, 1 OUS)