CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recalled
Foundation Medicine is recalling Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx), distributed nationwide in the US. The recall was initiated on 20 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1927-2026
- FDA event ID
- 98625
- Recalling firm
- Foundation Medicine, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Mar 2026
- FDA classified
- 22 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Mar 2026 | Recall initiated by company | |
| 22 Apr 2026 | Classified by FDA | +33 days |
| 29 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Product as listed by the FDA
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Where it was distributed
US Nationwide distribution in the states of Massachusetts and North Carolina.
Questions about this recall
Why was it recalled?
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Which lots are affected?
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
Where was it sold?
US Nationwide distribution in the states of Massachusetts and North Carolina.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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