{ "meta": { "disclaimer": "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "209600", "product_res_number": "Z-3246-2024", "event_date_initiated": "2024-08-01", "event_date_posted": "2024-09-24", "recall_status": "Open, Classified", "res_event_number": "95145", "product_code": "LON", "k_numbers": [ "K020321", "K040099", "K131331" ], "product_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.\nCatalog Number: 443624", "code_info": "UDI: 00382904436247\nAll serial numbers that have prior Phoenix M50 System Software Version 2.85.0.0 and PUD V7.41A", "firm_fei_number": "1119779", "recalling_firm": "Becton Dickinson & Co.", "address_1": "7 Loveton Cir", "city": "Sparks", "state": "MD", "postal_code": "21152-9212", "additional_info_contact": "SAME\n410-316-4000", "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,", "root_cause_description": "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:\n1. Immediately inspect your facility to identify if you have the affected product listed above. Reference Attachment 1 to confirm software version.\n2. Ensure the contents of this notification are read and understood by those within your organization.\n3. 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.\n4. It is not necessary to review previous test results and no additional clinical actions are recommended.\n5. 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.\n6. 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.\n\nBD has identified the root cause and will implement appropriate corrective actions to prevent recurrence of this issue.\n\nBD 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.\n\nNorth American Regional Complaint Center\nPhone: 1-844-8BD-LIFE (1-844-823-5433)\nSay Complaints when prompted Mon Fri 8:00am and 5:00pm CT\nor\nEmail: productcomplaints@bd.com\nProduct Complaints, Technical Questions\nRecall related questions: BDRC24@bd.com", "product_quantity": "4,295 (EA)", "distribution_pattern": "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\nQatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, \nSouth 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.", "openfda": { "k_number": [ "K032675", "K033784", "K023361", "K132507", "K083383", "K070860", "K023444", "K213899", "K113200", "K202396", "K132573", "K172944", "K091899", "K163563", "K050075", "K053186", "K050982", "K142170", "K181665", "K031429", "K121546", "K020506", "K210287", "K060444", "K020185", "K173252", "K051266", "K220546", "K043389", "K051311", "K092919", "K193572", "K063811", "K063365", "K082538", "K191766", "K062938", "K234000", "K080107", "K020871", "K020249", "K030091", "K032788", "K050002", "K041384", "K031943", "K031699", "K214023", "K022045", "K073406", "K103752", "K190905", "K023634", "K023273", "K020321", "K030677", "K062687", "K050555", "K061673", "K032131", "K042963", "K110106", "K052270", "K220805", "K051849", "K031601", "K162737", "K132674", "K071623", "K183524", "K063597", "K060447", "K020322", "K152075", "K051692", "K083536", "K032861", "K053241", "K050747", "K222378", "K032314", 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"3007502289", "3003030793", "3000215273", "3008007472", "3027320620", "1119779" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ] }