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 18 Jun 2024 and the FDA has classified it as Class II.
Check your package
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-1890-2025
- FDA event ID
- 96802
- Recalling firm
- Foundation Medicine, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jun 2024
- FDA classified
- 30 May 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Jun 2024 | Recall initiated by company | |
| 30 May 2025 | Classified by FDA | +346 days |
| 11 Jun 2025 | Published 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
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.
Product as listed by the FDA
FoundationOne Companion Diagnostic (F1CDx)
Where it was distributed
US Nationwide distribution in the state of MI.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.
Where was it sold?
US Nationwide distribution in the state of MI.
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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