United StatesSequencing Agent SEQ0067, a component of the FoundationOne CDx (F1CDx) test (Model SEQ0067; Lot numbers 24346, 24386, 24488; 163 units), distributed in the United States to facilities in Massachusetts and North Carolina, is affected. It was recalled due to a possible increase in phasing that could result in false‑positive BARD1 splice site indel artifact variants.
What's being recalled
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Recalling firm: Foundation Medicine, Inc., Cambridge, MA, United States.
How to identify it
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
The hazard
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of Massachusetts and North Carolina.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)