Notice names this product. BioFire Diagnostics’s Biofire Spotfire Respiratory/Sore Throat Panel REF is named in FDA Class II recall Z-2081-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Respiratory/sore throat panel test may result in false negative results and control failures. Identifying details: Lot Number: 2215125/UDI: 00815381020390. Units affected: 2400 pouches. 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.
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
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.
Respiratory/sore throat panel test may result in false negative results and control failures.
Company / brand: BioFire Diagnostics
Affected product: Biofire Spotfire Respiratory/Sore Throat Panel REF
Official ID Z-2081-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.