Notice names this product. BioFire Diagnostics’s BioFire Joint Infection (JI) Panel REF is named in FDA Class II recall Z-2067-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Contamination to in-vitro diagnostic test may result in false positives. Identifying details: Lot #s:0883425,0878825/DI: 00815381020192. Units affected: 106 kits (3,180 test). 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 Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
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.
Contamination to in-vitro diagnostic test may result in false positives.
Company / brand: BioFire Diagnostics
Affected product: BioFire Joint Infection (JI) Panel REF
Official ID Z-2067-2026 · 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.