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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

BioFire Respiratory Panel 2.1 plus Kits Recalled for False Negative Results

Agency Publication Date: May 29, 2025
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Summary

BioFire Diagnostics, LLC is recalling 30 units of the BioFire Respiratory Panel 2.1 plus Kit (REF: 423740) due to a manufacturing error. This error may cause the diagnostic test to fail or produce false negative results, meaning it may not detect respiratory infections in patients who are actually sick. No incidents or injuries have been reported at this time. Laboratory supervisors and healthcare providers should stop using these kits immediately and contact the manufacturer or their distributor for a replacement or correction.

Risk

The recalled test kits may provide false negative results for respiratory pathogens, which could lead to missed diagnoses, delayed treatment, or the unintentional spread of infectious diseases. If the test fails to detect a pathogen that is present, a patient might not receive the necessary care.

What You Should Do

  1. This recall affects the BioFire Respiratory Panel 2.1 plus Kit (REF: 423740) for Filmarray systems, specifically those belonging to Lot 1475424.
  2. Stop using the recalled product immediately and secure any remaining inventory from the affected lot to prevent further use.
  3. Contact BioFire Diagnostics, LLC or your authorized medical distributor to arrange for a return, replacement, or correction of the affected kits.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BioFire Respiratory Panel 2.1 plus Kit
Variants: For Filmarray systems
Model / REF:
423740
Lot Numbers:
1475424

Recall #: Z-1877-2025; Quantity: 30 kits

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96835
Status: Active
Manufacturer: BioFire Diagnostics, LLC
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 30 kits

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.