Z-3246-2024Class II

BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility...

Name: Z-3246-2024 BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility...
Creator: Becton Dickinson & Co.
Published: 2024-08-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2024-08-01 / Open, Classified

FDA source

Becton Dickinson & Co. began a recall of BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD... on 2024-08-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3246-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-01
Posted: 2024-09-24
Recalling firm: Becton Dickinson & Co
Product: 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
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for 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,
FDA root cause: Under Investigation by firm
Action: BD issued URGENT: Medical Device Product Correction letter to Distributors and End-users. Letter states reason for recall, health risk and action to take: 1. Immediately inspect your facility to identify if you have the affected product listed above. Reference Attachment 1 to confirm software version. 2. Ensure the contents of this notification are read and understood by those within your organization. 3. Continue use of the instrument. However, confirmatory testing should be performed on any gram-negative organism identified when there is laboratory evidence to suspect E. coli. until BD is able to perform the remediation to correct the issue. 4. It is not necessary to review previous test results and no additional clinical actions are recommended. 5. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 6. Complete the attached Customer Response Form and return to the BD contact, whether or not your you have the affected product noted on the form, so that BD may acknowledge your receipt of this notification per FDA requirements. BD has identified the root cause and will implement appropriate corrective actions to prevent recurrence of this issue. BD will contact your facility to schedule a service visit to provide an update to the PUD (Phoenix Update Data) and software to correct this issue. North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: [email protected] Product Complaints, Technical Questions Recall related questions: [email protected]
Quantity in commerce: 4,295 (EA)
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.
Product codes and lots: UDI: 00382904436247 All serial numbers that have prior Phoenix M50 System Software Version 2.85.0.0 and PUD V7.41A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3246-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3246-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3247-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24

Product code LON

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)