CLASS II · ModerateFDA

Foundation Medicine, Inc. recalls FoundationOne CDx

📅 Nov 8, 2022 · 📍 Nationwide

Recalling company: Foundation Medicine, Inc.
Product: FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Reason: 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.
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: Nov 8, 2022
Reported: Dec 3, 2025
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.
Status: Ongoing
Quantity: 59 units (39 US, 20 OUS)
Lot / codes: 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),
Company location: Cambridge, MA
Recall type: Voluntary: Firm initiated
Recall number: Z-0577-2026
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0577-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.