Notice names this product. Foundation Medicine’s Sequencing Agent SEQ0067 is named in FDA Class II recall Z-1927-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants Identifying details: Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.. Units affected: 163 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Company / brand: Foundation Medicine recalls
Affected product: Sequencing Agent SEQ0067 recall status
Official ID Z-1927-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.