BioFire Pneumonia Panel Plus Recall: False negatives from control failures
BioFire Diagnostics recalls Pneumoplus pneumonia test panels due to increased risk of false negatives from control failures. Affected units have specific UDI and lot numbers.
Lower-risk recall
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling its Pneumopl: Pneumonia Panel Plus (Pneumoplus) tests because they can give false negative results when used with multiplexed nucleic acid tests. This means the test might miss infections that are actually present. Read more at govinfonow.com/recall/52735-biofire-pneumonia-panel-plus-recall-false-negatives-from-control-failures.
Source Summary by GovInfoNow · govinfonow.com/recall/52735-biofire-pneumonia-panel-plus-recall-false-negatives-from-control-failures · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1518-2025
Cite this page
“BioFire Pneumonia Panel Plus Recall: False negatives from control failures.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52735-biofire-pneumonia-panel-plus-recall-false-negatives-from-control-failures. Based on FDA recall #Z-1518-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1518-2025%22&limit=1).
Why it’s dangerous
The test panels can fail to provide accurate results when used with multiplexed nucleic acid tests, leading to false negative results. This means the test might not detect pneumonia when it's actually present, potentially delaying proper treatment.
Who’s affected
People who use the Pneumoplus test panels for pneumonia diagnosis, especially those in healthcare settings. The risk is low for most users as the issue affects test accuracy rather than causing immediate harm.
How to tell if you have this one
Check for the product name 'Pneumoplus' and the unique device identifier (UDI) 00815381020314 or lot number 0979424. The recall covers specific units sold with these identifiers.
- Brand
BioFire Diagnostics- Category
Medical device
What to do — step by step
Check Product Details
Look for the UDI 00815381020314 or lot number 0979424 on the test panel packaging.
How this recall unfolded
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
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-1518-2025 (February 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1518-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.