FoundationOne Companion Diagnostic contains incorrect negative claims
Foundation Medicine is recalling two FoundationOne Companion Diagnostic (F1CDx) test reports that contained an incorrect negative claim on the claims page, though the device variant information displayed correctly in the tumor profiling section.
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 labeling or reporting error in a companion diagnostic test. The source states no illnesses or injuries were reported, and the critical tumor profiling information displayed correctly; the error was limited to an incorrect claim on the claims page, making this a moderate-severity labeling defect.
Plain-English summary
Foundation Medicine, Inc. is recalling two FoundationOne Companion Diagnostic (F1CDx) test reports distributed nationwide in Michigan. The recalled reports contained an incorrect negative claim displayed on the claims page of the FDA-approved test reports.
The device variant information was displayed correctly in the tumor profiling section of both affected reports. Customers received these reports with the incorrect claims page information. No further details regarding patient impact, corrective actions, or return procedures are specified in the available source material.
The recalled product
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Manufacturer
- Foundation Medicine, Inc.
- Hazard
- Affected units
- 2
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 Numbers: ORD-XXXXX77-01
Distribution
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