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Recall Observatory FDA recall evidence

Device product

FoundationOne Companion Diagnostic (F1CDx)

Z-1890-2025

June 18, 2024

Class II

Product summary

Firm
Foundation Medicine, Inc.
Event
Event 96802
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1890-2025

Official wording

Reason: 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.

Code information: Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.

Distribution pattern: US Nationwide distribution in the state of MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.