CLASS II ONGOING Device recall · Reported 11 Jun 2025 · FDA Enforcement Report

FoundationOne Companion Diagnostic (F1CDx) recalled

Foundation Medicine is recalling FoundationOne Companion Diagnostic (F1CDx), distributed nationwide in the US. The recall was initiated on 15 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReport Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.
Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1891-2025
FDA event ID
96804
Recalling firm
Foundation Medicine, Cambridge, MA
Classification
Class II
Status
Ongoing
Recall initiated
15 Feb 2023
FDA classified
30 May 2025
Reported
11 Jun 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

15 Feb 2023Recall initiated by company
30 May 2025Classified by FDA+835 days
11 Jun 2025Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

FoundationOne Companion Diagnostic (F1CDx)

Where it was distributed

US Nationwide distribution in the state of WI.

Nationwide Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Report Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.

Where was it sold?

US Nationwide distribution in the state of WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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