Sequencing Agent SEQ0067 Component Recalled for Potential False-Positive Results
Foundation Medicine is recalling Sequencing Agent SEQ0067, a component of the FoundationOne CDx test, due to a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a medical device recall (FDA Class II) involving a genomic sequencing component that produces diagnostic results. The potential for false-positive results in cancer genetic testing creates a direct risk of patient harm through incorrect medical decision-making, even though no reported illnesses or injuries are stated in the source text.
Plain-English summary
Foundation Medicine, Inc. is recalling Sequencing Agent SEQ0067, which is a component of the FoundationOne CDx (F1CDx) genomic testing system. The recall affects 163 units distributed nationwide in Massachusetts and North Carolina.
The recall was initiated due to a possible increase in phasing, which could potentially result in false-positive BARD1 splice site indel artifact variants being reported in test results.
Patients and healthcare providers who have received results from affected test units should contact Foundation Medicine or their healthcare provider to determine if their results may have been impacted by this issue.
The recalled product
- Product
- Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- Manufacturer
- Foundation Medicine, Inc.
- Affected units
- 163
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: SEQ0067. Lot Numbers: 24346
- 24386
- 24488.
Distribution
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