BioFire Pneumonia Test Kit May Give False Positives - Recall

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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 Diagnostics is recalling its FilmArray Pneumonia Panel (Pneumo) test kits because they may give false positive results. This could lead to unnecessary treatments or anxiety for users.

Why it’s dangerous

The test may incorrectly indicate pneumonia when it's not present. This could lead to unnecessary treatments or anxiety for patients. False positives might also cause delays in proper diagnosis.

Who’s affected

Healthcare providers using the FilmArray Pneumonia Panel (Pneumo) test kits for pneumonia diagnosis are most likely affected. Patients receiving false positive results may undergo unnecessary treatments.

How to tell if you have this one

Check the unique device identifier (UDI) on the kit: 00815381020178. All unexpired lots of the FilmArray Pneumonia Panel (Pneumo) with reference number FIT-ASY-0144 and CED 2797 are affected.

Brand
BioFire Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit UDI
Look for the unique device identifier (UDI) 00815381020178 on the test kit packaging.

✎ GovInfoNow

Questions people ask

Why is this test being recalled?

The recall is due to potential false positive results when using the FilmArray Pneumonia Panel (Pneumo) test kits.

What should I do if I have this test kit?

The official recall notice does not specify a remedy or action for affected kits.

Are there any specific model numbers for this recall?

The affected kits have reference number FIT-ASY-0144 and CED 2797 with UDI 00815381020178.

Take action

Contact BioFire Diagnostics

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

✉️ Open in email

Subject: Recall Z-0994-2024 — BioFire Diagnostics BioFire Diagnostics

Hello,

I own a BioFire Diagnostics that is covered by recall Z-0994-2024 from BioFire Diagnostics.

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-0994-2024 (December 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0994-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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 FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

Lower-risk recall