FoundationOne CDx test reports recalled for potential false positive results
Foundation Medicine is recalling eight FoundationOne CDx test reports due to identified potential false positive MSI-H results.
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 medical diagnostic test with a potential for false positive results, which constitutes a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Foundation Medicine, Inc. is recalling eight FoundationOne CDx test reports. The recall was initiated because the company identified potential false positive MSI-H (Microsatellite Instability-High) results on the test reports provided to physicians.
The affected reports were distributed to facilities in Massachusetts, North Carolina, Indiana, Ohio, and Georgia. The specific model/lot/serial numbers involved are QRF150009.01, QRF150228.01, QRF150108.01, QRF149795.01, QRF150117.01, QRF150247.01, QRF149634.01, and QRF128938.01.
Physicians and healthcare providers who received these reports should contact Foundation Medicine for further instructions regarding the potential inaccuracy of the MSI-H status.
The recalled product
- Product
- FoundationOne CDx test report
- Manufacturer
- Foundation Medicine, Inc.
- Hazard
- Affected units
- 8
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 (8)
- Model/Lot/Serial Number: QRF150009.01
- QRF150228.01
- QRF150108.01
- QRF149795.01
- QRF150117.01
- QRF150247.01
- QRF149634.01
- QRF128938.01
Distribution
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