FDA recall, , Moderate risk
Foundation Medicine FoundationOne CDx Sequencing Agent
Sequencing Agent SEQ0067 may increase phasing, potentially causing false-positive BARD1 splice site indel artifact variants.
Summary by Recall Canary from the FDA notice
What happened
Foundation Medicine, Inc., of Cambridge, Massachusetts, recalled 163 units of Sequencing Agent SEQ0067, a component of FoundationOne CDx (F1CDx), because of a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants. The company began the recall on March 20, 2026, and the FDA added it to the Enforcement Report on April 22, 2026. The product was distributed in the states of Massachusetts and North Carolina.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code is listed.
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- Lot code
- 24346
- 24386
- 24488
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Massachusetts and North Carolina.
- Company
- Foundation Medicine, Inc.Cambridge, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98625
- Recall number
- Z-1927-2026
- Quantity recalled
- 163 units
All recalls from Foundation Medicine, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
