The Recall Desk
ModerateFDA (Devices)·Z-0577-2026·Announced 2025-12-03

Cancer test reports recalled for omitting the companion diagnostic claims page

Foundation Medicine is recalling 59 FoundationOne CDx reports that were sent to customers without the companion diagnostic Claims Page.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites an omitted report page that the firm supplied within seven days, with no stated clinical consequence or reported harm.

Plain-English summary

FoundationOne CDx (F1CDx), RAL-0003 version 31.0, from Foundation Medicine, is the subject of a recall.

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. The firm states claims pages were distributed via amended reports within 7 days of the issue occurrence.

The recall covers 59 units, of which the record lists 39 in the United States and 20 outside it, identified by test number. Distribution was nationwide in the United States including Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey and Nevada. The FDA has classified the action as Class II.

The enforcement record describes a missing report page that was subsequently supplied, and reports no injuries. Sites should follow Foundation Medicine's instructions.

The recalled product

Product
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Manufacturer
Foundation Medicine, Inc.
Category
Medical Device — Diagnostic test
Hazard
  • incomplete-report
  • companion-diagnostic
  • documentation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category