Foundation Medicine Recalls 800 FoundationOne CDx Test Reports
Foundation Medicine is recalling 800 FoundationOne CDx test reports because an incorrect result for a single analyte may have been reported.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II medical device where incorrect test results may have been reported. This poses a risk of harm through potential misdiagnosis or inappropriate treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Foundation Medicine, Inc. is recalling 800 FoundationOne CDx Test Reports. The recall was initiated because an incorrect test result for a single analyte may have been reported in these documents.
The affected reports were distributed nationwide in the United States. The specific specimen numbers associated with this recall are listed in the official FDA record Z-0649-2019.
Physicians and healthcare providers who have received these reports should contact Foundation Medicine for further instructions on how to proceed with the affected patient results.
The recalled product
- Product
- FoundationOne CDx Test Results
- Manufacturer
- Foundation Medicine, Inc.
- Hazard
- Affected units
- 800
Distribution
Distributed nationwide across the United States.
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