FoundationOne Companion Diagnostic recall
FoundationOne Companion Diagnostic (F1CDx)
Why was FoundationOne Companion Diagnostic recalled?
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Recalling firm
- Foundation Medicine, Inc.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of MI.
- Recall date
- June 11, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)