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Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Recalled April 29, 2026 · FDA recall Z-1927-2026 · Foundation Medicine
Hazard
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants · FDA Class II
Units
163 units
Sold at
US Nationwide distribution in the states of Massachusetts and North Carolina.
Description
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Product
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Manufacturer(s)
Foundation Medicine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →