Reported Apr 29, 2026 · Ongoing
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Foundation Medicine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Foundation Medicine, Inc. · 150 2nd St · Cambridge, MA · 02141-2115
Is this the product you have?
Sequencing Agent SEQ0067component of FoundationOne CDx (F1CDx)
- Lot codes and dates
- Model NumberSEQ0067
- Lot Numbers
243462438624488
- Amount recalled
- 163 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
This product could cause temporary or reversible health problems — stop using it.
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