{ "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": "95158", "product_res_number": "Z-0366-2011", "event_date_initiated": "2010-05-14", "event_date_posted": "2010-11-15", "recall_status": "Terminated", "event_date_terminated": "2010-11-29", "res_event_number": "57001", "product_code": "LON", "k_numbers": [ "K021954" ], "product_description": "BD Phoenix\" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***", "code_info": "Lot 0083198 Exp 03/31/2011", "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": "Kim Cartier\n410-316-4000", "reason_for_recall": "The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.", "root_cause_description": "Packaging process control", "action": "BD Diagnostic Systems issued an \"Urgent Product Recall\" letter dated May 2010 to direct accounts, identifying the affected product, potential impact, and actions to be taken by the customer. Accounts were requested to respond by returning the enclosed reply form indicating the number of replacements needed for the affected product to be discarded.\nFor assistance iwth replacements, contact BD Customer Service at 800 675-0908. For other inquiries, contact BD Technical Services at 1 800-638-8663.", "product_quantity": "1675 units", "distribution_pattern": "Nationwide Distribution: To direct accounts in CA, MD, NJ, PA. and WI.", "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" } } ] }