Warning
Foundation Medicine Recalls Sequencing Agent SEQ0067
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1927-2026Medical Device
Foundation Medicine Recalls Sequencing Agent SEQ0067
Foundation Medicine, Inc. · Class II — Moderate Risk
Product Description
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Reason for Recall
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of Massachusetts and North Carolina.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Foundation Medicine, Inc. initiated the recall on March 20, 2026 affecting 163 units. Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants. The product was distributed in Massachusetts and North Carolina. Consumers should check their purchases and discontinue use of any affected product. Contact Foundation Medicine, Inc. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.