{ "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": "169023", "product_res_number": "Z-0639-2019", "event_date_initiated": "2018-11-13", "event_date_created": "2018-12-19", "recall_status": "Terminated", "event_date_terminated": "2021-07-07", "res_event_number": "81589", "product_code": "LON", "k_numbers": [ "K050002" ], "product_description": "VITEK 2 Systems Software Version 9.01 Update Kit.", "code_info": "Product Description: KIT UPDT VTK2 9.01 EN,   UDI: 03573026561260", "firm_fei_number": "3002769706", "recalling_firm": "bioMerieux, Inc.", "address_1": "100 Rodolphe St", "city": "Durham", "state": "NC", "postal_code": "27712-9402", "reason_for_recall": "The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP\" feature.", "root_cause_description": "Software design", "action": "bioMerieux notified customers of the recall on about 11/13/2018 via \"URGENT PRODUCT CORRECTION NOTICE.\" Instructions included taking the following actions: 1) Confirm the letter has been distributed to, and reviewed by, all appropriate personnel; 2) If appropriate in accordance with consignee's laboratory's Standard Operating Procedures, perform retrospective review of any patient results potentially impacted in relation to the described VITEK FLEXPREP anomaly; 3) Store this letter with the bioMrieux, Inc. VITEK 2 instrument documentation; 4) Complete and return the Acknowledgement Form in Attachment A to confirm receipt of the notice and return it to your local bioMrieux, Inc. representative. \n\nRegardless of each consignee's current use of the VITEK FLEXPREP\" feature, your local Field Service Engineer has implemented the software solution on your VITEK 2 System.\n\nIf you require additional assistance or have any questions, please contact your local bioMrieux, Inc. Clinical Customer Service representative at (800) 682-2666. \n\nFor non-urgent inquiries, please contact the Technical Support Center by email at CustomerService-IDAST@biomerieux.com. The anticipated turnaround time for email inquiries is 24-48 hours during normal business hours (7AM 7PM EST), and up to 72 hours dependent upon weekends and company observed holidays.", "product_quantity": "five (5) VITEK¿ 2 Systems Software version 9.01", "distribution_pattern": "Nationwide distribution to CO, IL, MO, TX.", "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" } } ] }