BioFire recalls 30-test Joint Infection Panel REF: RFIT-ASY-0138 due to contamination risk causing false positives in diagnostic tests. Affected units include specific lot numbers.
“BioFire Joint Infection Panel Recall: False Positives Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49401-biofire-joint-infection-panel-recall-false-positives-risk. Based on FDA recall #Z-2067-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2067-2026%22&limit=1).
BioFire Diagnostics, LLC recalled BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit due to contamination that may result in false positives, the FDA said on April 22, 2026.
Contamination to the in-vitro diagnostic test may result in false positives.
Context
GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since March 14, 2018. Other recent recalls of similar products include BioFire Respiratory Panel 2.1 (June 24, 2026), BioFire Spotfire Respiratory Panel Recall (April 1, 2026), and BioFire Respiratory Panel 2.1 Recall (Oct. 22, 2025).
How to tell if you have this one
Check the lot numbers on the packaging: 0883425 or 0878825. The product is a 30-test kit labeled as BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138.
Brand
BioFire
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Numbers
Look for lot numbers 0883425 or 0878825 on the BioFire Joint Infection Panel packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maryland, North Carolina, Texas, Utah.
Recall timeline
FDA published this recall 21 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-2067-2026 (April 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2067-2026 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.