Quick Facts at a Glance
- Recall Date
- November 8, 2022
- Hazard Level
- HIGH
- Brand
- Foundation Medicine
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Foundation Medicine
- Product type
- Diagnostic Test
- Model numbers
- F1CDX - RAL-0003 version 31.0, 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) +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 8, 2022
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Foundation Medicine, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The FoundationOne CDx is a genomic test that helps physicians make informed treatment decisions based on a patient's unique cancer profile. Patients typically use it to guide personalized therapy and improve treatment outcomes.
Why This Is Dangerous
The absence of the companion diagnostic Claims Page in the reports could lead to a lack of essential information for healthcare providers when making diagnosis and treatment decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may affect patients' access to personalized treatment plans, potentially delaying necessary care.
Practical Guidance
How to identify if yours is affected
- Check your FoundationOne CDx report for the presence of the companion diagnostic Claims Page.
- Contact Foundation Medicine directly to clarify if your test result is part of the recall.
- Keep any correspondence from Foundation Medicine regarding your test for records.
Where to find product info
Look for the FoundationOne CDx model number on the test report provided to you by the healthcare provider.
What timeline to expect
Expect to receive a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Contact Foundation Medicine customer service again if you do not hear back within the stated timeline.
- File a complaint with the FDA if your issues remain unaddressed.
How to prevent similar issues
- Inquire about the completeness of reports before using diagnostic tests in the future.
- Ensure that any diagnostic tests are certified and follow proper regulations.
Documentation advice
Keep a copy of the test report and all related communications with Foundation Medicine for your records.
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Product Details
Product: FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Quantity: 59 units (39 US, 20 OUS) Where Sold: Nationwide in the US and internationally, including Japan and Singapore Recall Date: November 8, 2022
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 59 units recalled (39 in the US, 20 international)
- Missing companion diagnostic Claims Page in reports
- No injuries or incidents reported
- Stop using the device immediately
- Contact Foundation Medicine for further instructions
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