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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

Becton Dickinson & Co.: BD Phoenix Microbiology Panels Recalled for Drug Contamination and Testing Errors

Agency Publication Date: March 29, 2024
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Summary

Becton Dickinson & Co. (BD) is recalling approximately 18,500 BD Phoenix NMIC-306 and Yeast ID diagnostic panels because some units were contaminated with drugs or incorrect substances during manufacturing. These panels are used by healthcare facilities to identify infections and determine which antibiotics or treatments will work best for a patient. If these defective panels are used, they may provide incorrect results, causing a doctor to prescribe the wrong medicine, an inadequate dose, or no treatment at all. The Yeast ID panels specifically may trigger a 'Fluorescent interference' error and cancel the test entirely due to the presence of an misplaced substance called Esculin.

Risk

The contamination can lead to incorrect or delayed lab results, which may result in patients receiving the wrong antibiotic treatment or no treatment for serious infections. In the case of the Yeast ID panels, the system may automatically abort the test, causing critical delays in patient diagnosis and care.

What You Should Do

  1. Check your inventory for BD Phoenix NMIC-306 Panels with Lot Number 3318700 and Expiration Date 07-NOV-2024 (UDI-DI: 30382904492923).
  2. Check your inventory for BD Phoenix Yeast ID Panels with Lot Number 3312180 and Expiration Date 30-OCT-2024 (UDI-DI: 30382904483167).
  3. Immediately stop using any panels from the affected lot numbers and quarantine them to prevent further use in patient testing.
  4. Contact Becton Dickinson & Co. (BD) at their Sparks, Maryland facility or through your local representative for specific instructions on returning the defective panels or obtaining replacements.
  5. If you are a patient and believe your treatment was based on a test using these panels, contact your healthcare provider to discuss if re-testing or treatment adjustments are necessary.
  6. For more information or to report technical issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BD Phoenix NMIC-306 Panel
Model / REF:
Z-1398-2024
UPC Codes:
30382904492923
Lot Numbers:
3318700 (Exp. Date: 07-NOV-2024)
Date Ranges: Expiration Date: 07-NOV-2024
Product: BD Phoenix Yeast ID Panel
Model / REF:
Z-1399-2024
UPC Codes:
30382904483167
Lot Numbers:
3312180 (Exp. Date: 30-OCT-2024)
Date Ranges: Expiration Date: 30-OCT-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94180
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Hospital laboratories; Diagnostic centers; Medical distributors
Manufactured In: United States
Units Affected: 2 products (11,800 eaches; 6700 eaches)
Distributed To: Nationwide

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.