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
- Companion Diagnostic Test
- Model numbers
- F1LCDx - TECH-0009 version 6.0, ORD-XXX6703-01 (JP), ORD-XXXX411-01 (US), ORD-XXXX128-01 (US), ORD-XXXX061-01 (US), ORD-XXXX270-01 (US), ORD-XXXXX94-01 (US), ORD-XXXX058-01 (US) +11 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
FoundationOne Liquid CDx is a liquid biopsy tumor profiling test used to identify genomic alterations for cancer treatment decisions.
Why This Is Dangerous
The defect is the absence of the CDx Claims Page in reports, which could affect the completeness of diagnostic information presented to clinicians.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Clinicians may rely on incomplete reports, potentially influencing treatment decisions.
Practical Guidance
How to identify if yours is affected
- 1. Review ORD numbers listed in the recall.
- 2. Compare with ORD numbers on your report.
- 3. Verify if your report includes the CDx Claims Page.
Where to find product info
Look for ORD-XXXX-XX identifiers on the report or accompanying documentation.
What timeline to expect
Remedies typically follow a recall process via manufacturer, with refunds/replacements coordinated within weeks.
If the manufacturer is unresponsive
- Escalate to Foundation Medicine support.
- File a complaint with FDA if needed.
How to prevent similar issues
- Verify CDx claims pages accompany reports in the future.
- Confirm presence of all required pages before relying on results.
- Keep a copy of recall notices and your ORD numbers.
Documentation advice
Maintain copies of the recall notice, ORD numbers, and all correspondence with the manufacturer.
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Product Details
Product: FoundationOne Liquid CDx (F1LCDx) TECH-0009 version 6.0. Quantity: 18 units (17 US, 1 OUS). Distribution: US nationwide in states including 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 Japan and Singapore. Model numbers include F1LCDx - TECH-0009 version 6.0 and ORD numbers such as ORD-XXX6703-01 (JP), ORD-XXXX411-01 (US), ORD-XXXX128-01 (US), ORD-XXXX061-01 (US), ORD-XXXX270-01 (US), ORD-XXXXX94-01 (US), ORD-XXXX058-01 (US), ORD-XXXX099-01 (US), ORD-XXXX089-01 (US), ORD-XXXX252-01 (US), ORD-XX
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US distribution across 25 states plus PR
- Overseas: Japan, Singapore
- ORD test numbers listed
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Safety Guide
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