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Foundation Medicine, Inc.: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Medical DevicesSource: FDA (device) · Date: 2026-04-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Foundation Medicine, Inc.
Product
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Reason / hazard
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of Massachusetts and North Carolina.
Recall initiated
2026-03-20
Code info
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
Product quantity
163 units
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
State
MA
Country
United States
Event id
98625
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