{ "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": "31833", "product_res_number": "Z-0725-04", "event_date_initiated": "2004-01-15", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2004-11-24", "res_event_number": "28429", "product_code": "LON", "product_description": "VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.", "code_info": "Lot P61X, Exp. 5/12/05", "firm_fei_number": "1950204", "recalling_firm": "bioMerieux Inc", "address_1": "595 Anglum Rd", "city": "Hazelwood", "state": "MO", "postal_code": "63042-2320", "additional_info_contact": "Nancy Weaver\n314-731-8595", "reason_for_recall": "The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.", "root_cause_description": "Other", "action": "The firm issued recall letters dated 1/15/04 via regular mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. The firm also issued a 'Second Notification' recall letter dated 3/9/04.", "product_quantity": "1,955/20-card boxes", "distribution_pattern": "Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.", "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" } } ] }