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

[pending] FoundationOne CDx (F1CDx), RAL-0003 version 31.0

Pending LLM rewrite. Source: FDA_DEVICE Z-0577-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Manufacturer
Foundation Medicine, Inc.
Category
Medical Device — Devices

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