BioFire recalls respiratory/sore throat test panels with risk of false negatives and control failures. Affected units include REF: 42348: 2215125 lot numbers.
“BioFire Spotfire Respiratory Panel Recall: False Negatives Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49575-biofire-spotfire-respiratory-panel-recall-false-negatives-risk. Based on FDA recall #Z-2081-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2081-2026%22&limit=1).
The FDA announced on April 1, 2026, that BioFire Diagnostics, LLC is recalling the Biofire Spotfire Respiratory/Sore Throat Panel (REF: 423485) due to potential false negative results and control failures. The voluntary Class II recall affects 2,400 pouches distributed nationwide and in Mississippi, Texas, Minnesota, and Virginia.
The respiratory/sore throat panel test may result in false negative results and control failures. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show BioFire Diagnostics, LLC has had 32 other recalls since March 14, 2018. Recent similar recalls include the BioFire Respiratory Panel 2.1 on June 24, 2026, and the BioFire Joint Infection Panel on April 22, 2026. Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel (July 16, 2026), the Meridian Bioscience Revogene C. difficile Test (Dec. 5, 2025), and the Biomerieux VITEK 2 AST-N461 Test Kit (July 24, 2026).
How to tell if you have this one
Check for the product code REF: 423485 and lot number 2215125 on the panel. The unique identifier (UDI) starts with 00815381020390.
Brand
BioFire
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Panel Details
Look for the product code REF: 423485 and lot number 2215125 on the panel.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of MS, TX MN, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Minnesota, Mississippi, Texas, Virginia.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2081-2026 (April 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2081-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.