{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184929", "product_res_number": "Z-0759-2021", "event_date_initiated": "2020-12-08", "event_date_created": "2020-12-31", "recall_status": "Terminated", "event_date_terminated": "2023-10-03", "res_event_number": "86963", "product_code": "LON", "product_description": "BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli\n\nCatalog Number: 448605 (Discontinued)", "code_info": "All unexpired lots UDI: 00382904486051", "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": "BD Customer/ Technical Support\n800-638-8663", "reason_for_recall": "BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection", "root_cause_description": "Nonconforming Material/Component", "action": "BD issued letters Urgent Medical Device Correction mailed beginning December 8, 2020 with FedEx tracking. \nLetter states reason for recall, health risk and action to take:\n1.Share this product correction notification with all BD Phoenix\" users within your facility network and post a copy near all BD Phoenix\" instruments until the revised User Manual is available.\n2. Respond to the product correction notification electronically by using the link BD.com/IDS-21-3976 or by returning to the attached Customer Response Form to the BD contact noted on the form so that BD may acknowledge your receipt of this notification per FDA requirements.\nReport any adverse health consequences experienced with the use of\nthis product to BD.\n\nTechnical Support\n800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States.\nFor customers outside of the United States, contact your local BD representative or distributor\n\nActions Taken by BD:\nBD is updating the BD Phoenix\" User Manual to provide additional guidance on use of the impacted panels and the manual is scheduled to be released by April 30, 2021. The revised manual will be accessible at bd.com/e-labeling.\nA BDXpert rule is also being developed to further assist customers on how to proceed with MIC readings for SXT. The BDXpert rule is set to be released by March 30, 2021 and will be included in the PUD update", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K030091", "K031984", "K050747", "K050075", "K061327", "K220805", "K023634", "K063301", "K132909", "K020185", "K032275", "K033889", "K023858", "K111976", "K020870", "K051692", "K063564", "K122547", "K053504", "K223478", "K024152", "K251713", "K050780", "K121100", "K031429", "K202396", "K072695", "K071268", "K023444", "K063811", "K220803", "K050400", "K063573", "K113783", "K020328", "K110106", "K020319", "K112000", "K141149", "K234012", "K083383", "K051138", "K122359", "K062944", "K121863", "K030677", "K113200", "K260282", "K021954", "K043458", "K061867", "K093076", "K161227", "K032655", "K033907", "K032766", "K070346", "K070809", "K063366", "K051272", "K031601", "K060214", "K214023", "K062945", "K033064", "K050982", "K050555", "K232756", "K061869", "K192110", "K172944", "K031865", "K080201", "K020322", "K063486", "K063824", "K113305", "K181665", "K073406", "K042946", "K061347", "K121546", "K052346", "K173252", "K033784", "K020323", "K233986", "K052656", "K052270", "K020511", "K052311", "K043237", "K062705", "K023361", "K083536", "K222430", "K091899", "K152075", "K032567", "K061673", "K211630", "K161217", "K062207", "K020173", "K082852", "K092919", "K063623", "K051478", "K040845", "K051311", "K033560", "K073083", "K212849", "K112129", "K232201", "K023527", "K051689", "K163006", "K020182", "K023568", "K172731", "K041384", "K082346", "K020397", "K040106", "K861958", "K260281", "K183551", "K211759", "K022129", "K033557", "K072668", "K020142", "K051266", "K060257", "K193299", "K031943", "K050816", "K201675", "K191766", "K230864", "K072038", "K024153", "K023895", "K193572", "K132674", "K111893", "K040006", "K032399", "K053241", "K063492", "K032675", "K041982", "K023301", "K123404", "K050089", "K250344", "K162737", "K211136", "K031589", "K060088", "K071623", "K163083", "K022045", "K052250", "K031679", "K023273", "K031699", "K073433", "K031912", "K063597", "K043230", "K161510", "K060444", "K020249", "K091126", "K070860", "K051204", "K050865", "K040099", "K042932", "K052269", "K111599", "K060312", "K222073", "K051350", "K073589", "K131331", "K213241", "K023541", "K071317", "K032711", "K033458", "K032861", "K032788", "K032153", "K071076", "K032314", "K020248", "K193567", "K132573", "K142170", "K020246", "K062687", "K112228", "K042963", "K020871", "K062206", "K033362", "K030986", "K051849", "K063365", "K163563", "K020398", "K082913", "K053097", "K050976", "K020413", "K223481", "K183524", "K050076", "K051109", "K063300", "K151320", "K050881", "K082538", "K080107", "K212243", "K051183", "K022172", "K251579", "K050002", "K032131", "K060447", "K033482", "K041572", "K181766", "K061355", "K062938", "K033558", "K190905", "K211748", "K032738", "K213899", "K112075", "K050946", "K111909", "K140468", "K060324", "K053186", "K103752", "K060493", "K234000", "K060218", "K031306", "K891577", "K050745", "K163637", "K190616", "K222378", "K220546", "K031530", "K173523", "K020168", "K131779", "K060558", "K161437", "K210287", "K030579", "K031602", "K020209", "K250447", "K213931", "K201405", "K040716", "K020321", "K183415", "K020410", "K060217", "K032299", "K062680", "K132507", "K123266", "K093224", "K020506", "K043389", "K200590", "K031410", "K183360" ], "pma_number": [ "N50487", "P800029", "N50061", "N50524", "P840065", "P810024", "N50525", "N50538", "P820073", "P800030", "N50531", "P870049" ], "registration_number": [ "3009288740", "1318354", "3013718871", "3025775667", "3025772277", "1111096", "3006198300", "3009637528", "3002444944", "2919016", "1423662", "3031977134", "3007502289", "3009171251", "1119779", "3023036790", "3008007472", "2022807", "1833407", "1950204", "3007344102", "3027320620", "3003030793" ], "fei_number": [ "1000518597", "3009288740", "1318354", "3013718871", "3025775667", "3025772277", "1111096", "3006198300", "3009637528", "3006759904", "3002444944", "2919016", "3031977134", "3007502289", "1119779", "3023036790", "3008007472", "2022807", "3000215273", "1950204", "3007344102", "3027320620", "3003030793" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ] }