{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "35890", "product_res_number": "Z-0268-05", "event_date_initiated": "2004-10-29", "event_date_posted": "2004-11-30", "recall_status": "Terminated", "event_date_terminated": "2005-01-31", "res_event_number": "30445", "product_code": "LON", "product_description": "BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels.", "code_info": "Lots: 3316699\t11/30/2004 4146868\t05/31/2005 4063959\t03/31/2005 4231466\t08/31/2005 3288384\t10/31/2004 3316697\t11/30/2004 4035990\t02/28/2005 4063276\t03/31/2005 4133618\t05/31/2005 4203249\t07/31/2005 4209161\t08/31/2005 4245919\t09/30/2005 4231472\t08/31/2005 4181008\t07/31/2005 4224731\t08/31/2005 4231473\t08/31/2005 4224708\t08/31/2005", "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 Service\n800-675-0908", "reason_for_recall": "The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results.", "root_cause_description": "Other", "action": "BD Diagnostic Systems notified end users by letter dated October 2004. The firm''s sales representatives delivered the letters initially on 10/29/04. The letter advises end users to examine identified lots for defects using a diagram provided with the notification and discard any suspect product for replacement. A response form is included with the notification.", "distribution_pattern": "Product was sold to direct accounts nationwide and to the firm''s affiliate distributors worldwide.", "openfda": { "k_number": [ "K250344", "K020173", "K043389", "K051692", "K020870", "K051689", "K060257", "K201405", "K193299", "K202396", "K024152", "K213899", "K161217", "K163006", "K041982", "K052250", "K031865", "K122359", "K060447", "K082538", "K032399", "K020413", "K023541", "K220546", "K050400", "K050865", "K050780", "K032675", "K061327", "K043237", "K040099", "K222430", "K033907", "K050076", "K061347", "K062938", "K073433", "K063366", "K033557", "K181766", "K020321", "K213931", "K080201", "K121546", "K122547", "K234000", "K172944", "K132674", "K032711", "K063300", "K061673", "K042932", "K060218", "K031589", "K032766", "K080107", "K093224", "K073406", "K020322", "K022045", "K050075", "K050089", "K082852", "K072668", "K073589", "K192110", "K193567", "K063573", "K070809", "K051350", "K051272", "K050002", "K043230", "K083536", "K072695", "K032788", "K091899", "K142170", "K033458", "K162737", "K161510", "K222378", "K214023", "K043458", "K111893", "K183551", "K023361", "K023568", "K121863", "K020142", "K023895", "K201675", "K032314", "K093076", "K232201", "K223478", "K082346", "K083383", "K251579", "K032655", "K030677", "K062687", "K033889", "K031912", "K022129", "K033560", "K050946", "K023634", "K070860", "K181665", "K031679", "K131331", "K020397", "K031601", "K183524", "K213241", "K023527", "K052270", "K063492", "K051266", "K052346", "K091126", "K032275", "K152075", "K031410", "K063597", "K050816", "K062945", "K073083", "K132573", "K123266", "K020185", "K023444", "K082913", "K020168", "K050982", "K032299", "K161437", "K033064", "K113305", "K031984", "K052269", "K022172", "K173523", "K260281", "K131779", "K063301", "K042963", "K140468", "K891577", "K051138", "K051849", "K113783", "K112075", "K020248", "K190905", "K060444", "K063365", "K233986", "K211136", "K061869", "K053097", "K060214", "K220805", "K040716", "K111976", "K200590", "K031306", "K041384", "K052311", "K132909", "K183415", "K212849", "K222073", "K211630", "K063564", "K050555", "K020410", "K032567", "K023858", "K020506", "K063486", "K071317", "K020249", "K023301", "K051183", "K030986", "K161227", "K020319", "K053504", "K030579", "K211748", "K112129", "K210287", "K062207", "K111909", "K103752", "K193572", "K190616", "K023273", "K123404", "K024153", "K020328", "K250447", "K060324", "K020871", "K051311", "K050881", "K063623", "K151320", "K040845", "K031699", "K053186", "K211759", "K020323", "K260282", "K232756", "K183360", "K040106", "K072038", "K031530", "K113200", "K070346", "K020182", "K033362", "K060312", "K061867", "K110106", "K092919", "K141149", "K050747", "K063824", "K030091", "K062206", "K062680", "K021954", "K051204", "K033558", "K060088", "K032153", "K053241", "K050976", "K031943", "K033482", "K062705", "K020398", "K020511", "K223481", "K251713", "K063811", "K052656", "K121100", "K212243", "K050745", "K031602", "K071076", "K230864", "K061355", "K172731", "K132507", "K032738", "K173252", "K060493", "K032861", "K071268", "K163637", "K031429", "K040006", "K163563", "K112000", "K220803", "K042946", "K041572", "K163083", "K234012", "K060558", "K191766", "K060217", "K062944", "K051478", "K020246", "K861958", "K071623", "K032131", "K111599", "K112228", "K020209", "K033784", "K051109" ], "pma_number": [ "N50538", "P840065", "P810024", "N50531", "P800030", "P870049", "N50525", "P800029", "N50487", "N50061", "N50524", "P820073" ], "registration_number": [ "3013718871", "3008007472", "1423662", "3009637528", "3009288740", "1111096", "3027320620", "3031977134", "2022807", "1833407", "3003030793", "1950204", "1119779", "1318354", "3009171251", "3025772277", "3006198300", "3023036790", "3002444944", "3025775667", "2919016", "3007344102", "3007502289" ], "fei_number": [ "3013718871", "3008007472", "3009637528", "3009288740", "1111096", "3027320620", "3006759904", "3031977134", "3000215273", "2022807", "3003030793", "1950204", "1000518597", "1119779", "1318354", "3025772277", "3023036790", "3006198300", "3002444944", "3025775667", "2919016", "3007344102", "3007502289" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ] }