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.
Sources: FDA openFDA Enforcement Database