{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114682", "product_res_number": "Z-0570-2013", "event_date_initiated": "2012-11-06", "event_date_posted": "2012-12-19", "recall_status": "Terminated", "event_date_terminated": "2013-01-09", "res_event_number": "63737", "product_code": "LON", "k_numbers": [ "K070809" ], "product_description": "BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA.\r\n\r\nThe BD Phoenix\" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.", "code_info": "Lot number 2053373", "firm_fei_number": "1119779", "recalling_firm": "Becton Dickinson & Co.", "address_1": "7 bd diagnostic systems loveton circle", "city": "Sparks", "state": "MD", "postal_code": "21152-0999", "additional_info_contact": "Ms. Gail Claiborne\n410-316-4054", "reason_for_recall": "An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, BD, sent an \"URGENT PRODUCT RECALL\" letter dated November 2012 via the telephone and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and discard any remaining packages for replacement and to complete and return the Acknowledgement Receipt Form, whether or not you have any inventory remaining, via fax to: BD Regulatory Compliance at 410-316-4258. BD will issue replacements for the discarded materials.\r\n\r\nIf further assistance is needed regarding replacements please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.", "product_quantity": "12,250 tests", "distribution_pattern": "Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.", "openfda": { "k_number": [ "K053186", "K103752", "K223478", "K093076", "K071268", "K033557", "K053241", "K092919", "K040006", "K063300", "K043230", "K050780", "K020506", "K161217", "K220805", "K230864", "K031601", "K190905", "K232201", "K031943", "K111893", "K043458", "K062938", "K121100", "K861958", "K140468", "K051849", "K051183", "K050816", "K163006", "K020323", "K020249", "K032567", "K063492", "K061867", "K250447", "K122359", "K113783", "K033482", "K082852", "K020871", "K020248", "K070346", "K220803", "K201405", "K060088", "K052250", "K213931", "K020398", "K031912", "K032655", "K071076", "K051138", "K020182", "K050089", "K173523", "K251579", "K113200", "K152075", "K032711", "K060324", "K071623", "K032399", "K161227", "K033558", "K062945", "K051689", "K061347", "K042932", "K063824", "K050946", "K032766", "K041572", "K201675", "K023568", "K050002", "K052311", "K032299", "K023634", "K071317", "K020321", "K211748", "K183551", "K161437", "K062207", "K073433", "K121546", "K131331", "K183415", "K053097", "K020173", "K033362", "K212849", "K041384", "K060558", "K082346", "K222430", "K033907", "K051204", "K063366", "K060217", "K162737", "K063486", "K080107", "K043237", "K060447", "K063564", "K233986", "K020185", "K172731", "K062680", "K061327", "K181766", "K023541", "K891577", "K032153", "K032131", "K020511", "K020410", "K163083", "K063811", "K050745", "K020319", "K032788", "K020397", "K020870", "K040845", "K030986", "K052270", "K032675", "K122547", "K020142", "K250344", "K222073", "K060312", "K123266", "K234012", "K020246", "K032861", "K023301", "K031984", "K070809", "K031602", "K031429", "K050976", "K132507", "K062687", "K031530", "K022172", "K083536", "K024152", "K033458", "K051266", "K083383", "K223481", "K210287", "K052656", "K183524", "K132573", "K063597", "K031699", "K050400", "K032314", "K192110", "K051311", "K072668", "K062206", "K050076", "K110106", "K123404", "K030091", "K032275", "K181665", "K060214", "K053504", "K131779", "K232756", "K082538", "K022129", "K050881", "K080201", "K111976", "K211630", "K111909", "K132674", "K251713", "K051350", "K060218", "K202396", "K063573", "K032738", "K073589", "K060257", "K050555", "K173252", "K200590", "K063365", "K220546", "K093224", "K063623", "K072695", "K213899", "K023361", "K031679", "K040106", "K061673", "K062705", "K141149", "K113305", "K070860", "K193299", "K033560", "K030579", "K051692", "K121863", "K062944", "K112000", "K042963", "K214023", "K024153", "K043389", "K023273", "K021954", "K260282", "K142170", "K091899", "K260281", "K091126", "K031306", "K151320", "K161510", "K041982", "K061869", "K211759", "K023444", "K033064", "K040099", "K072038", "K060444", "K073406", "K033889", "K172944", "K073083", "K183360", "K051478", "K112075", "K050075", "K042946", "K061355", "K060493", "K031410", "K052346", "K023527", "K050982", "K023895", "K020328", "K191766", "K051272", "K112228", "K050865", "K020413", "K052269", "K020322", "K111599", "K132909", "K163637", "K222378", "K163563", "K020209", "K020168", "K212243", "K234000", "K030677", "K213241", "K112129", "K193567", "K040716", "K031589", "K082913", "K190616", "K023858", "K031865", "K193572", "K022045", "K050747", "K211136", "K051109", "K063301", "K033784" ], "pma_number": [ "N50061", "P810024", "N50524", "P870049", "N50531", "P820073", "P840065", "P800030", "N50525", "N50487", "P800029", "N50538" ], "registration_number": [ "3009288740", "2919016", "3008007472", "3027320620", "3013718871", "3006198300", "2022807", "3031977134", "1833407", "3003030793", "3025772277", "3009637528", "3009171251", "1950204", "3025775667", "1318354", "1119779", "1111096", "3002444944", "3007502289", "3007344102", "3023036790", "1423662" ], "fei_number": [ "3009288740", "2919016", "3008007472", "3027320620", "3013718871", "3006198300", "2022807", "3031977134", "3003030793", "3000215273", "3025772277", "3009637528", "1950204", "3025775667", "1318354", "1119779", "1111096", "1000518597", "3002444944", "3007502289", "3007344102", "3023036790", "3006759904" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ] }