FDAClass II · Medical device · Recall Z-2067-2026 · Recalled May 13, 2026

BioFire Joint Infection (JI) Panel REF recall — BioFire Diagnostics, LLC

Agency report date: May 13, 2026.

1. Compare your item

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.

Product named: BioFire Joint Infection (JI) Panel REF
Company / brand: BioFire Diagnostics
Lot / serial / date codes: Lot #s:0883425,0878825/DI: 00815381020192
Distribution: Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.

Agency product description and boundaries

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.

2. Agency hazard and consumer action

FDA reports: Contamination to in-vitro diagnostic test may result in false positives.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: BioFire Joint Infection (JI) Panel REF

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2067-2026
Brand: BioFire Diagnostics
Classification: Class II
Units affected: 106 kits (3,180 test)
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

BioFire Joint Infection (JI) Panel REF

Companies & origin

Recalling firm location: Salt Lake City, UT, United States
Firm address: 515 S Colorow Dr, 84108-1248

Identifying details (verbatim from the notice)

Product codes / lots: Lot #s:0883425,0878825/DI: 00815381020192
Distribution: Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.
Firm notified the public via: E-Mail
FDA event ID: 98776
Recall initiated: April 22, 2026
FDA classified: May 6, 2026
FDA report date: May 13, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved August 11, 2026 at 6:00 PM UTC.

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