FoundationOne Companion Diagnostic reports clinically relevant variants requiring amendment
Foundation Medicine is recalling four FoundationOne Companion Diagnostic (F1CDx) test reports sent to customers that contained clinically relevant variants requiring amendment, including one with an incorrect negative companion diagnostic claim.
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 test report errors that could affect clinical decision-making. The source does not report any confirmed illnesses or injuries, and most reports (3 of 4) did not impact diagnostic indications, making this a moderate-level precautionary recall.
Plain-English summary
Foundation Medicine, Inc. is recalling four (4) FoundationOne Companion Diagnostic (F1CDx) test reports that were sent to customers. The reports contained clinically relevant variants that require amendment.
Of the four reports, one contained an incorrect negative companion diagnostic claim. The remaining three reports contained tumor profiling result changes but did not impact companion diagnostic indications.
Affected customers who received these reports should contact Foundation Medicine, Inc. for corrected results and guidance on the appropriate clinical actions based on the amended findings.
The recalled product
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Manufacturer
- Foundation Medicine, Inc.
- Affected units
- 4
Distribution
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