{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221078", "product_res_number": "Z-2715-2026", "event_date_initiated": "2026-06-04", "event_date_posted": "2026-07-09", "recall_status": "Open, Classified", "res_event_number": "99213", "product_code": "LON", "product_description": "VITEK 2 AST-N447 TEST KIT\nProduct reference 424620", "code_info": "Lot 0853293604\n\nUDI-DI 03573026634551\n\nProduct is not registered in the US. OUS only.", "firm_fei_number": "1950204", "recalling_firm": "Biomerieux Inc", "address_1": "595 Anglum Rd", "city": "Hazelwood", "state": "MO", "postal_code": "63042-2320", "additional_info_contact": "bioMerieux Customer Service Center\n314-731-8526", "reason_for_recall": "Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.", "root_cause_description": "Process change control", "action": "Firm began notifying customers on June 4, 2026.\n\nCustomers are instructed to dispose of pouches from the affected lot (Ref 424620, Lot 0853293604). Customer may choose to inspect each pouch in their inventory and only dispose of those with \"P7\" on the label, or they may choose to dispose of all cards from Lot 0853293604 in their inventory.\n\nBased on individual customer policy, customers may wish to perform retrospective review of resistant results.\n\nCustomers should distribute the information to all appropriate personnel in their laboratory. If product was transferred or further distributed, customer should notify downstream users/accounts.", "product_quantity": "45,900 cards", "distribution_pattern": "International distribution to the countries of Belgium and the Netherlands.", "openfda": { "k_number": [ "K020173", "K023444", "K211136", "K051109", "K083383", "K232756", "K053241", "K183524", "K052250", "K032738", "K063301", "K050747", "K032675", "K200590", "K080107", "K031429", "K043237", "K091899", "K033064", "K053186", "K024152", "K070860", "K051478", "K023273", "K163083", "K250447", "K211759", "K063564", "K220805", "K032275", "K212243", "K023634", "K050865", "K063811", "K063597", "K030677", "K234012", "K060447", "K032567", "K062938", "K062705", "K123404", "K121100", "K023361", "K050976", "K050400", "K024153", "K041572", "K112075", "K163563", "K040716", "K073083", "K161217", "K251713", "K023301", "K040845", "K033560", "K212849", "K201675", "K891577", "K053097", "K112000", "K161227", "K060257", "K050075", "K033482", "K122547", "K023858", "K063824", "K062207", "K020248", "K031679", "K113200", "K131331", "K213931", "K223478", "K193572", "K051692", "K020182", "K111909", "K222073", "K050089", "K173252", "K163637", "K071076", "K123266", "K122359", "K030579", "K072038", "K023568", "K070809", "K220546", "K033458", "K092919", "K052346", "K022129", "K173523", "K032655", "K071623", "K031602", "K031306", "K063623", "K023895", "K031912", "K020511", "K020142", "K022172", "K031530", "K033362", "K032861", "K042932", "K050002", "K042963", "K050745", "K070346", "K051138", "K051350", "K020209", "K033557", "K061869", "K131779", "K063492", "K063366", "K032766", "K052656", "K080201", "K121863", "K061355", "K112228", "K060324", "K061347", "K132507", "K072695", "K060558", "K211748", "K043389", "K061673", "K062687", "K053504", "K172944", "K210287", "K091126", "K060444", "K071268", "K193299", "K251579", "K063300", "K033558", "K052311", "K063573", "K162737", "K113305", "K073589", "K020323", "K222378", "K051204", "K161437", "K030091", "K020319", "K031943", "K183360", "K020413", "K073433", "K032399", "K020506", "K132674", "K050982", "K030986", "K033889", "K031601", "K141149", "K032131", "K111976", "K220803", "K142170", "K140468", "K233986", "K190905", "K082913", "K020397", "K050780", "K040106", "K040006", "K051272", "K060217", "K061327", "K111893", "K031589", "K063486", "K031410", "K020321", "K232201", "K192110", "K213241", "K260282", "K042946", "K172731", "K060214", "K861958", "K051849", "K103752", "K020246", "K050816", "K112129", "K040099", "K020398", "K072668", "K121546", "K050076", "K032711", "K020871", "K183551", "K043458", "K234000", "K032788", "K031865", "K082852", "K083536", "K193567", "K151320", "K020322", "K020870", "K031699", "K062945", "K214023", "K051183", "K051311", "K062206", "K050881", "K152075", "K163006", "K230864", "K250344", "K023527", "K062680", "K051689", "K020328", "K093076", "K191766", "K060218", "K202396", "K041384", "K020168", "K033784", "K223481", "K211630", "K060088", "K043230", "K063365", "K110106", "K093224", "K032299", "K060312", "K020410", "K023541", "K052269", "K082538", "K022045", "K161510", "K050946", "K190616", "K181766", "K071317", "K201405", "K222430", "K020249", "K082346", "K051266", "K032314", "K260281", "K181665", "K041982", "K033907", "K061867", "K183415", "K052270", "K031984", "K050555", "K073406", "K113783", "K060493", "K062944", "K020185", "K021954", "K111599", "K032153", "K132909", "K132573", "K213899" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2", "pma_number": [ "N50538", "P800030", "N50487", "P820073", "P840065", "N50525", "P800029", "P870049", "N50531", "P810024", "N50524", "N50061" ], "registration_number": [ "1318354", "3013718871", "3025772277", "3003030793", "3023036790", "1950204", "3031977134", "3009637528", "1119779", "2022807", "3009171251", "3002444944", "1423662", "2919016", "1833407", "1111096", "3006198300", "3007344102", "3008007472", "3027320620", "3007502289", "3009288740", "3025775667" ], "fei_number": [ "1318354", "3013718871", "3025772277", "3003030793", "3023036790", "1950204", "3031977134", "3009637528", "1119779", "2022807", "3000215273", "3002444944", "2919016", "3006759904", "1111096", "1000518597", "3006198300", "3007344102", "3008007472", "3027320620", "3007502289", "3009288740", "3025775667" ] } } ] }