← FDA ENFORCEMENT
Z-1927-2026Class II
Foundation Medicine, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Foundation Medicine, Inc.
Product type
Device
Status
Ongoing
Report date
2026-04-29
Distribution
US Nationwide distribution in the states of Massachusetts and North Carolina.
Firm state
MA
Product quantity
163 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Product description
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Code / lot info
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →