BioFire Pneumonia Panel Recall: False Results Risk
BioFire Diagnostics recalls Pneumonia Panel (Penumo) REF RFIT-ASY-014: elevated false positives/negatives and control failures due to manufacturing issues. Affected units include specific lot numbers and model.
Lower-risk recall
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling its Pneumonia Panel (Penumo) REF RFIT-ASY-0144 because it can give false positive or false negative results and fail controls due to manufacturing issues. This could lead to incorrect pneumonia diagnoses and treatment decisions. Read more at govinfonow.com/recall/62777-biofire-pneumonia-panel-recall-false-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62777-biofire-pneumonia-panel-recall-false-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1944-2021
Cite this page
“BioFire Pneumonia Panel Recall: False Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62777-biofire-pneumonia-panel-recall-false-results-risk. Based on FDA recall #Z-1944-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1944-2021%22&limit=1).
Why it’s dangerous
The panel can produce false positive or false negative results and fail control tests due to manufacturing defects. This means it might incorrectly indicate pneumonia when it's not present or miss actual pneumonia cases, leading to wrong treatment decisions.
Who’s affected
Healthcare providers using the Pneumonia Panel for testing are most at risk, as inaccurate results could affect patient care decisions.
How to tell if you have this one
Check for the product name 'Pneumonia Panel (Penumo)' with part number RFIT-ASY-0144. Affected units include specific lot numbers: Kit Lot# 0938121 and Pouch Lot# 19T621.
- Brand
BioFire Diagnostics- Category
Medical device
What to do — step by step
Check Product Details
Look for the part number RFIT-ASY-0144 and lot numbers Kit Lot# 0938121 or Pouch Lot# 19T621 on the panel packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Minnesota, Oklahoma.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1944-2021 (April 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1944-2021 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.