FoundationOne Companion Diagnostic (F1CDx)
Reported: June 11, 2025 Initiated: February 15, 2023 #Z-1891-2025
Product Description
FoundationOne Companion Diagnostic (F1CDx)
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.
Details
- Recalling Firm
- Foundation Medicine, Inc.
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of WI.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
FoundationOne Companion Diagnostic (F1CDx). Recalled by Foundation Medicine, Inc.. Units affected: 1 unit.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2025. Severity: Moderate. Recall number: Z-1891-2025.
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