BioFire Respiratory Panel 2.1 Recall: False negatives due to manufacturing error
BioFire Diagnostics recalls Respiratory Panel 2.1 plus Kit (REF: 423740) for possible false negative results from manufacturing errors. Affected units may need replacement.
Lower-risk recall
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Contact the company
What happened, in plain English
BioFire Diagnostics is recalling its Respiratory Panel 2.1 plus Kit (REF: 423740) because a manufacturing error could cause false negative results. This means test results might be inaccurate, potentially leading to missed diagnoses. Read more at govinfonow.com/recall/52365-biofire-respiratory-panel-2-1-recall-false-negatives-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/52365-biofire-respiratory-panel-2-1-recall-false-negatives-due-to · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1877-2025
Cite this page
“BioFire Respiratory Panel 2.1 Recall: False negatives due to manufacturing error.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52365-biofire-respiratory-panel-2-1-recall-false-negatives-due-to. Based on FDA recall #Z-1877-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1877-2025%22&limit=1).
Why it’s dangerous
A manufacturing error in the panel could cause the test to show a negative result when the patient actually has a respiratory infection. This might lead to missed diagnoses if the test is not properly functioning.
Who’s affected
Healthcare providers using the BioFire Respiratory Panel 2.1 plus Kit for respiratory testing are likely affected. Those testing patients for respiratory infections could be at risk of inaccurate results.
How to tell if you have this one
Check for the product name 'BioFire Respiratory Panel 2.1 plus Kit' with reference number 423740. The lot number 1475424 is also associated with this recall.
- Brand
BioFire- Category
Medical device
What to do — step by step
Check Product Details
Verify the product name, reference number 423740, and lot number 1475424 to confirm if your unit is affected.
How this recall unfolded
Recall timeline
FDA published this recall 35 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.
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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-1877-2025 (April 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1877-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.