FoundationOne Companion Diagnostic F1CDx Incorrect Claim Display
Foundation Medicine is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim displayed on the claims page, though device variant information was correctly shown in the tumor profiling section of the approved test report.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a display/labeling error where correct information was available in an alternate section of the report. No illnesses or injuries are reported, and the hazard is informational rather than health-risk-based.
Plain-English summary
Foundation Medicine, Inc. is recalling the FoundationOne Companion Diagnostic (F1CDx) nationwide in Wisconsin. An incorrect negative claim was identified on the claims page of the device. However, the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Patients and healthcare providers who have received test results should review the tumor profiling section of the approved test report, where the correct device variant information is available. Any questions or concerns should be directed to the recalling firm.
The recalled product
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Manufacturer
- Foundation Medicine, Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 1
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 (1)
- Report Number: ORD-XXXXX04-01
Distribution
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