FoundationOne CDx (F1CDx), RAL-0003 version 31.0

Class I - Dangerous

🏥 Medical Devices Recalled: November 8, 2022 Foundation Medicine Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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),
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:: 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 CDx (F1CDx), RAL-0003 version 31.0

Product Codes/Lot Numbers:

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),

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0577-2026

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