🔍 RecallPedia

FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

Class I - Dangerous
🏥 Medical Devices Recalled: November 8, 2022 Foundation Medicine Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    F1LCDx - TECH-0009 version 6.0; Test Numbers: 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-XXXX640-01 (US), ORD-XXX5300-01 (US), ORD-XXXX453-01 (US), ORD-XXXX101-01 (US), ORD-XXXX070-01 (US), ORD-XXXX231-01 (US), ORD-XXXX496-01 (US), ORD-XXXX202-01 (US),
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
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 I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

Product Codes/Lot Numbers:

F1LCDx - TECH-0009 version 6.0; Test Numbers: 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-XXXX640-01 (US), ORD-XXX5300-01 (US), ORD-XXXX453-01 (US), ORD-XXXX101-01 (US), ORD-XXXX070-01 (US), ORD-XXXX231-01 (US), ORD-XXXX496-01 (US), ORD-XXXX202-01 (US),

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0578-2026

Related Recalls

FoundationOne Companion Diagnostic (F1CDx)

Foundation Medicine

Class I - Dangerous

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.

Feb 15, 2023 Diagnostic Equipment Nationwide View Details →

FoundationOne Companion Diagnostic (F1CDx)

Foundation Medicine

Class I - Dangerous

Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.

Jun 18, 2024 Diagnostic Equipment Nationwide View Details →