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Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Class II
Recalling firm
Foundation Medicine, Inc.
Reason for recall
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Distribution pattern
US Nationwide distribution in the states of Massachusetts and North Carolina.
State
MA
Status
Ongoing
Recall number
Z-1927-2026
Recall initiated
March 20, 2026
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