{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215020", "product_res_number": "Z-2671-2025", "event_date_initiated": "2025-06-26", "event_date_posted": "2025-09-29", "recall_status": "Open, Classified", "res_event_number": "97269", "product_code": "LON", "product_description": "VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n.\n\nVITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.\n\nExport only", "code_info": "Material Number/Material Description/Batch Number:\n423936\tAST-N412 TEST KIT 20 CARDS \t0143139204\n423936\tAST-N412 TEST KIT 20 CARDS \t0143254504\n423936\tAST-N412 TEST KIT 20 CARDS \t0143303504\n424196\tAST-N427 TEST KIT 20 CARDS \t0542849204\n424196\tAST-N427 TEST KIT 20 CARDS \t0543190104\n424196\tAST-N427 TEST KIT 20 CARDS \t0543266504\n424196\tAST-N427 TEST KIT 20 CARDS \t0542951404\n424196\tAST-N427 TEST KIT 20 CARDS \t0543190104\n424196\tAST-N427 TEST KIT 20 CARDS \t0543289404\n424499\tAST-N438 TEST KIT 20 CARDS \t0703181504\n424499\tAST-N438 TEST KIT 20 CARDS \t0703218104\n424499\tAST-N438 TEST KIT 20 CARDS \t0703273104\n424499\tAST-N438 TEST KIT 20 CARDS \t0703125104\n424501\tAST-N439 TEST KIT 20 CARDS \t0723192104\n424501\tAST-N439 TEST KIT 20 CARDS \t0723048404\n424501\tAST-N439 TEST KIT 20 CARDS \t0722971504\n424501\tAST-N439 TEST KIT 20 CARDS \t0723237504\n424501\tAST-N439 TEST KIT 20 CARDS \t0722860204\n424502\tAST-N440 TEST KIT 20 CARDS \t0733170404\n424502\tAST-N440 TEST KIT 20 CARDS \t0733317504\n424502\tAST-N440 TEST KIT 20 CARDS \t0733170404\n424541\tAST-N443 TEST KIT 20 CARDS \t0773230404\n424541\tAST-N443 TEST KIT 20 CARDS \t0773247404\n424541\tAST-N443 TEST KIT 20 CARDS \t0772911104\n424587 AST-N444 TEST KIT 20 CARDS 0802553214\n424587 AST-N444 TEST KIT 20 CARDS 0802553204\n424620\tAST-N447 TEST KIT 20 CARDS \t0853198104\n424620\tAST-N447 TEST KIT 20 CARDS \t0853247204\n424633\tAST-N448 TEST KIT 20 CARDS \t0862971204\n424633\tAST-N448 TEST KIT 20 CARDS \t0863202504\n424633\tAST-N448 TEST KIT 20 CARDS \t0863296504\n424839 AST-N462 TEST KIT 20 CARDS No Lots\n424840 AST-N463 TEST KIT 20 CARDS No Lots\n424842 AST-N465 TEST KIT 20 CARDS No Lots\n424891\tAST-N475 TEST KIT 20 CARDS \t1703184204\n424891\tAST-N475 TEST KIT 20 CARDS \t1703225504\n424934\tAST-N476 TEST KIT 20 CARDS \t1713192504\n425019\tAST-N477 TEST KIT 20 CARDS \t1733184104\n425019\tAST-N477 TEST KIT 20 CARDS \t1733205204\n425019\tAST-N477 TEST KIT 20 CARDS \t1733205214\n424197\tAST-XN21 TEST KIT 20 CARDS \t0493174204\n424197\tAST-XN21 TEST KIT 20 CARDS \t0493310504\n424199\tAST-XN22 TEST KIT 20 CARDS \t0552981204\n424199\tAST-XN22 TEST KIT 20 CARDS \t0553156204\n424351\tAST-XN24 TEST KIT 20 CARDS \t0653042204\n424351\tAST-XN24 TEST KIT 20 CARDS \t0653217504\n424394 AST-XN25 TEST KIT 20 CARDS 0662155104\n424394 AST-XN25 TEST KIT 20 CARDS 0662553204\n424586\tAST-XN28 TEST KIT 20 CARDS \t0793210504\n424586\tAST-XN28 TEST KIT 20 CARDS \t0793265504\n424586\tAST-XN28 TEST KIT 20 CARDS \t0793295504\n424586\tAST-XN28 TEST KIT 20 CARDS \t0793210504\n424604\tAST-XN29 TEST KIT 20 CARDS \t0822932204\n424604\tAST-XN29 TEST KIT 20 CARDS \t0823262504\n424810\tAST-XN35 TEST KIT 20 CARDS \t1323087204\n424888\tAST-XN37 TEST KIT 20 CARDS \t1693079204\n\nAST-XN25 424394 Australia AST-N412 423936 Thailand AST-XN21 424197 Turkey AST-XN22 424199 Iberia AST-N427 424196 Iberia AST-XN24 424351 Germany AST-N439 424501 Italy AST-N440 424502 Italy AST-XN28 424586 France AST-N443 424541 France, Spain & Portugal AST-N444 424587 Russia AST-N447 424620 Netherlands AST-N448 424633 Israel AST-XN35 424810 Poland AST-N462 424839 Taiwan AST-N463 424840 Taiwan AST-N465 424842 Taiwan AST-XN37 424888 Japan AST-N475 424891 Pakistan AST-N476 424934 Pakistan AST-N477 425019 India AST-N438 424499 Italy AST-XN29 424604 Japan", "firm_fei_number": "3002769706", "recalling_firm": "bioMerieux, Inc.", "address_1": "100 Rodolphe St", "city": "Durham", "state": "NC", "postal_code": "27712-9402", "additional_info_contact": "bioMerieux Customer Service Center\n800-682-2666", "reason_for_recall": "Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards", "root_cause_description": "Under Investigation by firm", "action": "On 06/27/2025, the firm sent an \"URGENT FIELD SAFETY NOTICE\" letter to customer informing them that VITEK 2 users, who are using VITEK 2 GN-AST cards with Colistin formulation, cs02n, have reported obtaining false resistant Colistin results with Acinetobacter baumannii complex and Pseudomonas aeruginosa isolates.\n\nCustomers are required to:\nbioMrieux recommends you confirm any resistant colistin (cs02n) results for multidrug resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex isolates via an alternate method for all existing and future AST cards with cs02n.\nIf appropriate for your laboratory, create a custom bioART rule to show when resistant colistin (cs02n) results are obtained for Pseudomonas aeruginosa and Acinetobacter baumannii complex isolates (refer to the VITEK 2 Software User Manual for instructions).\nBased on individual facility policy, you may wish to perform retrospective review of resistant results.\nDistribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred the product.\nComplete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMrieux even if you determine that this product correction notice does not impact your facility.\n\nFor questions or further assistance, contact the local bioMerieux Customer Service Representative.", "product_quantity": "235269 cards", "distribution_pattern": "International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkey.", "openfda": { "k_number": [ "K022045", "K042963", "K214023", "K023895", "K172944", "K063623", "K122359", "K183360", "K110106", "K200590", "K260281", "K024153", "K020168", "K060217", "K060493", "K061347", "K173252", "K251579", "K051692", "K031602", "K053186", "K062687", "K072695", "K091126", "K173523", "K060218", "K220803", "K181665", "K060088", "K181766", "K032314", "K211759", "K183415", "K050982", "K191766", "K020506", "K031679", "K062944", "K073589", "K051689", "K051204", "K082538", "K063597", "K060558", "K043237", "K111893", "K132507", "K023301", "K032275", "K031865", "K151320", "K033482", "K050076", "K232201", "K063564", "K050780", "K031410", "K051350", "K051849", "K161217", "K023273", "K051138", "K063492", "K050400", "K163006", "K140468", "K201405", "K020209", "K070860", "K050745", "K060444", "K190616", "K113200", "K132573", "K202396", "K073433", "K040099", "K161510", "K020410", "K193299", "K032153", "K020398", "K163563", "K183551", "K251713", "K201675", "K032675", "K060257", "K030986", "K033560", "K050002", "K233986", "K062206", "K213899", "K051183", "K062938", "K250447", "K051478", "K063824", "K050881", "K041384", "K042946", "K060324", "K210287", "K032711", "K020249", "K051272", "K092919", "K063573", "K103752", "K032788", "K132909", "K063365", "K021954", "K043389", "K032655", "K051266", "K083536", "K111599", "K040716", "K190905", "K071268", "K082913", "K033362", "K023361", "K063300", "K093076", "K212243", "K050976", "K112129", "K222378", "K861958", "K891577", "K230864", "K020142", "K032131", "K112075", "K213931", "K030091", "K152075", "K031429", "K020322", "K031943", "K033064", "K060312", "K071623", "K020328", "K020871", "K063486", "K220805", "K022129", "K023858", "K041572", "K050089", "K032738", "K023541", "K121546", "K211748", "K050946", "K050075", "K093224", "K041982", "K052656", "K161227", "K023527", "K032567", "K161437", "K080201", "K050816", "K020248", "K123266", "K223478", "K020246", "K053097", "K052269", "K122547", "K023634", "K112228", "K083383", "K050555", "K121100", "K222073", "K061867", "K062680", "K131779", "K061673", "K062945", "K053504", "K111976", "K033907", "K141149", "K163637", "K123404", "K052346", "K032299", "K043458", "K132674", "K073406", "K050747", "K020870", "K061355", "K033784", "K211630", "K040106", "K030677", "K071317", "K193572", "K020185", "K050865", "K020511", "K053241", "K040845", "K060214", "K043230", "K091899", "K061869", "K052270", "K211136", "K032399", "K063366", "K192110", "K051109", "K250344", "K183524", "K020397", "K022172", "K031530", "K212849", "K082346", "K111909", "K031984", "K033889", "K032766", "K033458", "K030579", "K023444", "K113305", "K032861", "K060447", "K080107", "K113783", "K193567", "K033557", "K142170", "K042932", "K033558", "K223481", "K031601", "K234012", "K234000", "K020319", "K222430", "K163083", "K072038", "K172731", "K131331", "K162737", "K031589", "K031306", "K260282", "K031699", "K121863", "K052250", "K220546", "K023568", "K024152", "K232756", "K070346", "K070809", "K020321", "K020413", "K031912", "K063811", "K072668", "K020323", "K061327", "K063301", "K082852", "K213241", "K071076", "K062207", "K020182", "K020173", "K052311", "K040006", "K073083", "K112000", "K051311", "K062705" ], "pma_number": [ "N50487", "P800030", "N50525", "N50531", "N50524", "P820073", "P810024", "P870049", "N50061", "P800029", "N50538", "P840065" ], "registration_number": [ "1950204", "1111096", "1423662", "3009637528", "2919016", "3027320620", "3025772277", "3008007472", "2022807", "3003030793", "3009171251", "3009288740", "3007344102", "3013718871", "1833407", "3002444944", "3025775667", "1318354", "3007502289", "1119779", "3006198300", "3031977134", "3023036790" ], "fei_number": [ "1950204", "1111096", "3009637528", "2919016", "1000518597", "3027320620", "3025772277", "3000215273", "3008007472", "2022807", "3003030793", "3009288740", "3007344102", "3013718871", "3006759904", "3002444944", "3025775667", "1318354", "3007502289", "1119779", "3006198300", "3031977134", "3023036790" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ] }