Sequencing Agent SEQ0067 recall (Foundation Medicine, Inc.)
Medical deviceClass IIOngoing
Summary: Foundation Medicine, Inc. is recalling Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx). Reason: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants.
What is being recalled
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Why
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of Massachusetts and North Carolina. (states named: Massachusetts, North Carolina)
How to tell if yours is affected
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1927-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 20, 2026 |
| Reported | April 29, 2026 |
| Company | Foundation Medicine, Inc. |
| Company location | Cambridge, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 163 units |
More recalls from Foundation Medicine, Inc. · all medical device recalls · recalls from March 2026