FoundationOne Companion Diagnostic recall
FoundationOne Companion Diagnostic (F1CDx)
Why was FoundationOne Companion Diagnostic recalled?
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
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?
ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.
- Product
- FoundationOne Companion Diagnostic (F1CDx)
- Recalling firm
- Foundation Medicine, Inc.
- Quantity
- 4 units
- Distribution
- Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
- Recall date
- May 21, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)