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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 M50 and 100 Instruments Recalled for E. coli Misidentification

Agency Publication Date: September 24, 2024
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Summary

Becton Dickinson & Co. has recalled 5,059 BD Phoenix M50 and BD Phoenix 100 diagnostic instruments because they may misidentify Escherichia coli (E. coli) in clinical samples. These instruments are used by healthcare facilities to identify bacteria and determine which antibiotics will be effective against an infection. The defect involves specific software versions and could lead to patients receiving an incorrect diagnosis or improper medical treatment for E. coli infections. This recall affects 4,295 BD Phoenix M50 units and 764 BD Phoenix 100 units distributed worldwide.

Risk

If the instrument incorrectly identifies E. coli, a patient might be diagnosed with the wrong type of infection or given an antibiotic that is not effective against their actual illness. This can delay proper treatment and lead to more severe health complications from the underlying E. coli infection.

What You Should Do

  1. Identify if your facility is using the affected BD Phoenix M50 (Catalog Number 443624) or BD Phoenix 100 (Catalog Number 448100) instruments.
  2. For the BD Phoenix M50, check if the instrument is running System Software Version prior to 2.85.0.0 and PUD V7.41A. The UDI for these units is 00382904436247.
  3. For the BD Phoenix 100, all serial numbers under UDI 00382904481001 are affected.
  4. Contact Becton Dickinson & Co. or your healthcare provider to discuss the software update and any necessary changes to testing protocols or patient results.
  5. For additional information or technical support regarding this software issue, contact the manufacturer, Becton Dickinson & Co., directly at their Sparks, Maryland facility located at 7 Loveton Cir.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information on this device recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Software Update

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

Affected Products

Product: BD Phoenix M50 instrument
Model / REF:
Catalog Number: 443624
UPC Codes:
00382904436247
Lot Numbers:
All serial numbers with software version prior to 2.85.0.0 and PUD V7.41A
Product: BD Phoenix 100 instrument
Model / REF:
Catalog Number: 448100
UPC Codes:
00382904481001
Lot Numbers:
All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95145
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Becton Dickinson & Co.; Medical distributors
Manufactured In: United States
Units Affected: 2 products (4,295 (EA); 764 (EA))
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.