Lower risk Medical device recall · FDA · Published August 1, 2024

BD Phoenix M5: E. coli misidentification risk in clinical testing

Becton Dickinson recalls BD Phoenix M50 instruments that may misidentify E. coli, leading to incorrect treatment. Affected units have specific software versions and serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3246-2024Medical device Becton Dickinson ›

Lower-risk recall

Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,

Take action

Contact the company

Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212

✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling BD Phoenix M50 instruments that could misidentify E. coli bacteria in clinical tests. This risk may lead to incorrect diagnoses and inappropriate treatments for infections. Read more at govinfonow.com/recall/54342-bd-phoenix-m5-e-coli-misidentification-risk-in-clinical-testing.

Source Summary by GovInfoNow · govinfonow.com/recall/54342-bd-phoenix-m5-e-coli-misidentification-risk-in-clinical-testing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3246-2024

Cite this page

“BD Phoenix M5: E. coli misidentification risk in clinical testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54342-bd-phoenix-m5-e-coli-misidentification-risk-in-clinical-testing. Based on FDA recall #Z-3246-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3246-2024%22&limit=1).

The FDA announced on 2024-08-01 that Becton Dickinson & Co. is recalling the BD Phoenix M50 instrument due to a hazard involving Escherichia coli misidentification. This error may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli, according to the FDA.

How to tell if you have it

Brand: Becton Dickinson
Product: BD Phoenix M50 instrument
Catalog Number: 443624
UDI: 00382904436247
Software Version: prior Phoenix M50 System Software Version 2.85.0.0 and PUD V7.41A
Distribution: Worldwide distribution including US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, United Republic of Thailand, Timor-Leste, Trinidad And Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, Vietnam, Zambia, Zimbabwe

The hazard

Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix M50 instrument and BD Phoenix 100 may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli, according to the FDA.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since 2017-06-01. Other recent recalls include the BD GasPak EZ Campy Pouch System Recall (2026-04-07), the BD Kiestra Isolate Suspension Cuvette Array recall (2025-10-23), and a product catalog security issue (2025-09-23). Other recent recalls of similar products include the Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05), Changchun Wancheng Bio-Electron UTI Test Strips Recall (2025-11-22), and the Becton Dickinson Luer Tip Caps Recall (2025-10-14).

How to tell if you have this one

Check for serial numbers with prior Phoenix M50 System Software Version 2.85.0.0 and PUD V7.41A. The instrument is sold under catalog number 443624 and UDI 00382904436247.

Brand
Becton Dickinson
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic Ecuador, Egypt, El Salvador, Ethiopia, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Syrian Arab, Republic Taiwan, Tanzania, United Republic of Thailand, Timor-Leste, Trinidad And Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, Vietnam, Zambia, Zimbabwe.

Recall number	Product, codes & lots	Quantity
Z-3246-2024	BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 443624; UDI: 00382904436247 All serial numbers that have prior Phoenix M50 System Software Version 2.85.0.0 and PUD V7.41A	4,295 (EA)
Z-3247-2024	BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100; UDI: 00382904481001 All serial numbers	764 (EA)

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your instrument's software version and PUD version to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Aug 1, 2024Firm started the recall
Sep 24, 2024FDA classified it Class II
Oct 2, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/54342-bd-phoenix-m5-e-coli-misidentification-risk-in-clinical-testing">BD Phoenix M5: E. coli misidentification risk in clinical testing (GovInfoNow)</a>

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-3246-2024 (August 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3246-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.