BioFire Joint Infection Panel Recall: False Positives Risk

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Contact the company & request your remedy

Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

BioFire is recalling its Joint Infection (JI) Panel test kits because they may cause false positive results. This could lead to incorrect diagnoses and unnecessary treatments if used without proper care.

Why it’s dangerous

The test kits may become contaminated during manufacturing, leading to false positive results. This could cause incorrect diagnoses of joint infections, potentially resulting in unnecessary treatments or delays in proper care.

Who’s affected

Users of the BioFire Joint Infection Panel test kits with lot numbers 0883425 or 0878825 are affected. Healthcare providers and individuals using these kits for joint infection testing are most at risk.

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.

✎ GovInfoNow

Questions people ask

What is the specific model of the recalled test kits?

The recalled product is BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, a 30-test kit.

What should I do if I have the recalled test kits?

Check the lot numbers on the packaging. If they match 0883425 or 0878825, contact BioFire for instructions.

Is there a risk of serious injury from using these kits?

The hazard is contamination causing false positives, which does not involve physical injury. This is a low-risk issue.

Take action

Contact BioFire

We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2067-2026 — BioFire BioFire

Hello,

I own a BioFire that is covered by recall Z-2067-2026 from BioFire.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

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.

BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Lower-risk recall