{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114200", "product_res_number": "Z-0790-2013", "event_date_initiated": "2012-08-21", "event_date_posted": "2013-02-06", "recall_status": "Terminated", "event_date_terminated": "2013-06-04", "res_event_number": "63555", "product_code": "JTN", "product_description": "Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific)\r\n\r\nAn antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam).", "code_info": "Lot 1100699", "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": "Earleen C. Parks\n913-888-0939", "reason_for_recall": "The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.", "root_cause_description": "Nonconforming Material/Component", "action": "ThermoFisher sent an Important Medical Device Product Recall Notice dated August 17, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review results reported using this lot and consider restesting and/or seek approproiate expert advice. Customers were requested to destroy any remaining inventory of the affected lot and contact Customer Services or their local Oxoid supplier who will issue a replacement. Customer were asked to return the attached \"Acknowledgement & Receipt Form by FAX to 1-877-428-1922 or 1-913-895-4190. Customers with questions were instructed to call the Technical Support Department at 800-255-6730 (US) or 913-888-0939 (International).\r\nFor questions regarding this recall call 913-888-0939.", "product_quantity": "30", "distribution_pattern": "Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX.", "openfda": { "k_number": [ "K000201", "K833709", "K760701", "K002656", "K970831", "K192326", "K821262", "K011086", "K812571", "K250454", "K892718", "K892733", "K943407", "K982523", "K812916", "K852967", "K855135", "K820019", "K984513", "K260842", "K000261", "K992568", "K002369", "K003556", "K892725", "K852689", "K822394", "K003536", "K250885", "K971637", "K000930", "K832956", "K002367", "K994129", "K000304", "K973488", "K822832", "K961819", "K810546", "K892719", "K934100", "K922791", "K052853", "K821264", "K971632", "K850357", "K982520", "K921193", "K982517", "K813441", "K920131", "K992647", "K181975", "K992507", "K801474", "K870870", "K860895", "K870175", "K902082", "K873829", "K181700", "K872938", "K892729", "K000829", "K855206", "K000022", "K000128", "K982526", "K802194", "K860536", "K183298", "K020842", "K170127", "K921282", "K261853", "K961188", "K000526", "K993577", "K001728", "K892730", "K892724", "K910506", "K172621", "K002368", "K062245", "K842292", "K924846", "K922793", "K000181", "K082272", "K832515", "K970385", "K865034", "K892735", "K002661", "K920473", "K892721", "K924765", "K982528", "K992077", "K832910", "K994212", "K971633", "K833414", "K992562", "K193508", "K971120", "K964489", "K860153", "K930946", "K892713", "K974578", "K191931", "K994051", "K992646", "K980683", "K920787", "K850957", "K010537", "K964487", "K830956", "K812525", "K980955", "K003532", "K010536", "K964492", "K971211", "K983718", "K894829", "K924766", "K241060", "K971638", "K982235", "K994091", "K003690", "K000305", "K082271", "K801473", "K842253", "K860527", "K851622", "K000440", "K873707", "K970830", "K922794", "K971635", "K822809", "K851228", "K900344", "K052876", "K000762", "K963508", "K203336", "K993993", "K210873", "K935975", "K821229", "K833415", "K931799", "K250956", "K982524", "K932052", "K892715", "K832909", "K973489", "K823800", "K852835", "K994150", "K994063", "K253105", "K892726", "K930702", "K000258", "K895392", "K070262", "K002663", "K992546", "K842307", "K152838", "K964490", "K003537", "K000203", "K812844", "K924797", "K232276", "K964491", "K251337", "K000175", "K003554", "K850358", "K000525", "K261781", "K931289", "K100722", "K890344", "K231568", "K923952", "K230651", "K944275", "K964512", "K871674", "K843172", "K892717", "K810427", "K994134", "K802178", "K830732", "K002660", "K050062", "K994067", "K833416", "K093807", "K831153", "K850606", "K001489", "K193504", "K964421", "K000302", "K892722", "K994046", "K984036", "K992420", "K152516", "K221826", "K011384", "K964501", "K984608", "K931290", "K000524", "K874256", "K895679", "K842252", "K251879", "K103538", "K931530", "K994132", "K961818", "K001490", "K042157", "K000272", "K892728", "K000182", "K812524", "K850607", "K812994", "K993186", "K891772", "K870201", "K000183", "K925969", "K892727", "K112586", "K870348", "K000268", "K000259", "K000928", "K893754", "K864848", "K992593", "K974394", "K864756", "K000130", "K993994", "K843725", "K933118", "K231806", "K965159", "K940359", "K002664", "K001487", "K250789", "K992076", "K994089", "K963845", "K921420", "K812228", "K810564", "K811377", "K060286", "K971631", "K970212", "K080019", "K992717", "K964495", "K892723", "K002165", "K000509", "K000271", "K003686", "K981517", "K831179", "K973479", "K973487", "K892720", "K994135", "K972098", "K964496", "K982669", "K955669", "K171975", "K910412", "K930911", "K872783", "K870347", "K203700", "K230827", "K852873", "K992297", "K152846", "K992853", "K182357", "K933657", "K080998", "K813387", "K011385", "K002662", "K971636", "K801648", "K812783", "K920786", "K800540", "K964493", "K812993", "K992726", "K892714", "K925060", "K982519", "K874425", "K830731", "K832653" ], "pma_number": [ "N60242" ], "registration_number": [ "8020667", "2647876", "3035367039", "3012389632", "8010096", "1119779", "2022807", "3013661582", "2030652", "2032112", "3004111573" ], "fei_number": [ "3000205059", "3006224287", "2647876", "3035367039", "3012389632", "2022807", "1119779", "4247", "3013661582", "3003076831", "3004111573" ], "device_name": "Susceptibility Test Discs, Antimicrobial", "medical_specialty_description": "Microbiology", "regulation_number": "866.1620", "device_class": "2" } } ] }