{ "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": "196740", "product_res_number": "Z-0331-2023", "event_date_initiated": "2022-10-20", "event_date_posted": "2022-12-08", "recall_status": "Terminated", "event_date_terminated": "2024-09-30", "res_event_number": "91104", "product_code": "JWY", "k_numbers": [ "K060621", "K073424", "K860753", "K880641", "K936305", "K983244" ], "product_description": "Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST", "code_info": "Lot Numbers: B2125, B2115", "firm_fei_number": "1924669", "recalling_firm": "Remel Inc", "address_1": "12076 Santa Fe Trail Dr", "city": "Lenexa", "state": "KS", "postal_code": "66215-3519", "additional_info_contact": "Tom Campbell\n913-895-4077", "reason_for_recall": "An internal technical investigation has confirmed that Thermo Scientific\" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.", "root_cause_description": "Process control", "action": "The firm issued an \"Urgent Medical Device Correction\" notice to its consignees on 10/25/2022 by US mail. The notice explained the issue, risk to health, and notified the consignees of an update to the IFU, specifically, \"to add limitations for Carbapenems (Imipenem, Doripenem, Meropenem, Ertapenem), Cefepime, Piperacillin/Tazobactam and Aztreonam added for users to \"NOT REPORT\" any result for each member of the Protea tribe (including Proteus spp., Providencia spp., Morganella Morganii) to address false susceptible results.\"\n\nPlease complete and return the Required Customer Reply form via email to MBD.vigilance@thermofisher.com. Please keep this notification on file. \n\nThe notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. \n\nThis correction notification is being made and performed by the US agent, Remel Inc., on behalf of the Foreign Manufacturer of the affected product, Trek Diagnostic Systems Ltd., located in East Grinstead, UK. Trek Diagnostic Systems and Remel Inc., both part of Thermo Fisher Scientific, are investigating the root cause and will implement corrective actions to prevent future recurrence.\n\nIf you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.", "product_quantity": "588 units", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K023202", "K992296", "K983027", "K883798", "K060621", "K192250", "K031205", "K230935", "K153569", "K001573", "K001036", "K945997", "K951879", "K250856", "K883555", "K874727", "K950328", "K882911", "K972180", "K861187", "K993679", "K974362", "K854099", "K181708", "K151873", "K894189", "K922003", "K042392", "K992059", "K944753", "K242905", "K062839", "K181889", "K922780", "K963107", "K021037", "K883554", "K942089", "K010363", "K991925", "K961519", "K191953", "K202423", "K894514", "K944651", "K882300", "K910345", "K883552", "K910346", "K001035", "K911558", "K924500", "K971376", "K983301", "K133773", "K060783", "K972567", "K911305", "K013075", "K252062", "K874426", "K180339", "K190109", "K200180", "K981139", "K181946", "K250575", "K020822", "K896965", "K935485", "K081325", "K883394", "K911391", "K140985", "K150236", "K883550", "K960220", "K073424", "K896566", "K901598", "K183140", "K111429", "K021110", "K983486", "K161175", "K983259", "K882912", "K020820", "K853862", "K200308", "K193024", "K960990", "K992143", "K961517", "K861584", "K003868", "K960235", "K926545", "K911303", "K984144", "K172542", "K021188", "K143288", "K163517", "K980877", "K173209", "K242021", "K883551", "K862446", "K000596", "K981137", "K933746", "K984489", "K052366", "K180330", "K904523", "K021997", "K062816", "K062722", "K000298", "K062022", "K133847", "K960989", "K971694", "K940917", "K990297", "K020037", "K202612", "K844903", "K231988", "K001516", "K052091", "K022775", "K171906", "K863847", "K021627", "K001612", "K040619", "K911186", "K981134", "K894146", "K941317", "K853805", "K970210", "K020937", "K021181", "K252014", "K012565", "K173307", "K902739", "K896332", "K870074", "K980773", "K941997", "K014258", "K093865", "K883076", "K032706", "K934323", "K935519", "K192345", "K183115", "K004045", "K141651", "K854577", "K953422", "K251580", "K933709", "K983571", "K142151", "K163298", "K041776", "K950817", "K983746", "K062681", "K854102", "K020331", "K945433", "K953223", "K854103", "K933885", "K223844", "K980347", "K180886", "K180936", "K951241", "K020762", "K946126", "K150556", "K033119", "K102535", "K172150", "K883800", "K081182", "K032518", "K172274", "K231994", "K882909", "K930055", "K240445", "K981639", "K031103", "K073558", "K191908", "K943510", "K020748", "K190252", "K013580", "K990685", "K983890", "K883553", "K021169", "K982868", "K981138", "K882301", "K854098", "K083606", "K192729", "K861186", "K932917", "K980338", "K162854", "K031545", "K021018", "K955920", "K881846", "K061536", "K910484", "K980342", "K911390", "K931069", "K242659", "K011803", "K960991", "K021339", "K970820", "K200512", "K192738", "K983922", "K882029", "K962867", "K973695", "K062783", "K241967", "K051202", "K001547", "K911392", "K182922", "K861408", "K021445", "K232310", "K170670", "K170892", "K922458", "K141000", "K193538", "K862978", "K022656", "K963641", "K883548", "K983711", "K020556", "K860195", "K030933", "K951539", "K911187", "K252114", "K911304", "K092445", "K972524", "K983953", "K012921", "K012895", "K864069", "K980603", "K936305", "K073653", "K020691", "K980345", "K911555", "K880617", "K173817", "K955910", "K980348", "K971951", "K153687", "K171870", "K093741", "K882299", "K001953", "K032259", "K043589", "K211672", "K911389", "K911557", "K913459", "K020859", "K190154", "K061687", "K911556", "K250990", "K870663", "K243202", "K020938", "K013423", "K912965", "K172454", "K981136", "K882910", "K965190", "K910242", "K860753", "K942267", "K943756", "K182797", "K143381", "K152346", "K933849", "K926294", "K003834", "K954319", "K850833", "K183031", "K983943", "K854097", "K041534", "K881716", "K062190", "K950123", "K951240", "K874876", "K964203", "K883549", "K972688", "K983252", "K001558", "K944517", "K042331", "K102668", "K203741", "K992108", "K980335", "K882477", "K962794", "K001887", "K081520", "K862560", "K242658", "K903589", "K923684", "K112276", "K893977", "K232395", "K922168", "K014259", "K854525", "K922926", "K930469", "K895796", "K062841", "K031727", "K990722", "K896278", "K984581", "K191809", "K801805", "K911559", "K172109", "K242653", "K862140", "K860369", "K143526", "K012151", "K932082", "K870719", "K880641", "K260696", "K934380", "K895215", "K912613", "K863776", "K243169", "K020686", "K250274", "K944723", "K925644", "K183324", "K911185", "K854101", "K182557", "K042390", "K864891", "K183527", "K260447", "K970676", "K941459", "K912778", "K923045", "K880598", "K854100", "K984491", "K946364", "K880430", "K912846", "K243201", "K884510", "K041214", "K040846", "K242657", "K111615", "K904689", "K964236", "K242843", "K884831", "K032382", "K912964", "K152774", "K170772", "K970473", "K093604", "K971697", "K864493", "K874466", "K884509", "K983408", "K983565", "K142338", "K984087", "K183033", "K981135", "K934458", "K013925", "K192050", "K190914", "K033522", "K020162", "K210757", "K230479", "K121002", "K192355", "K905853" ], "pma_number": [ "P830028" ], "registration_number": [ "9615754", "3003750284", "1530126", "1119779", "3013661582", "2919016", "3012389632", "1924669", "8021914" ], "fei_number": [ "3003750284", "1119779", "1000515493", "3013661582", "3002806332", "2919016", "3012389632", "1924669", "3008237827" ], "device_name": "Manual Antimicrobial Susceptibility Test Systems", "medical_specialty_description": "Microbiology", "regulation_number": "866.1640", "device_class": "2" } } ] }