FoundationOne CDx test report
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Foundation Medicine, Inc.
- Reason for Recall:
- Identified potential false positive MSI-H on the test reports provided to the physicians.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
FoundationOne CDx test report
Product Codes/Lot Numbers:
Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01
Distribution:
Distributed in: MA, NC, IN, OH, GA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0535-2020
Related Recalls
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Foundation Medicine
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.
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Foundation Medicine
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.
FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.