BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-3246-2024 · Reported October 2, 2024

    Enforcement

    Recall Number
    Z-3246-2024
    Event ID
    95145
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2024
    Initiation Date
    August 1, 2024
    Classification Date
    September 24, 2024
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212, United States

    Description

    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

    Reason

    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,

    Code Info

    UDI: 00382904436247 All serial numbers that have prior Phoenix M50 System Software Version 2.85.0.0 and PUD V7.41A

    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.

    Quantity

    4,295 (EA)