{ "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": 4 } }, "results": [ { "cfres_id": "167356", "product_res_number": "Z-0171-2019", "event_date_initiated": "2018-08-24", "event_date_created": "2018-10-17", "recall_status": "Terminated", "event_date_terminated": "2020-04-29", "res_event_number": "81052", "product_code": "KIT", "product_description": "Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use", "code_info": "Lot# 1986670 Exp.Date 30-Dec-2019. Lot# 1995631 Exp. Date 31-Jan-2020.  UDI: 10190302001731", "firm_fei_number": "1317268", "recalling_firm": "Life Technologies, Corp.", "address_1": "3175 Staley Rd", "city": "Grand Island", "state": "NY", "postal_code": "14072-2028", "additional_info_contact": "Chance Lai\n240-379-4394", "reason_for_recall": "Leaky bottles due to a defect in the bottle cap compromising the sterility of the product", "root_cause_description": "Under Investigation by firm", "action": "Thermo Fisherr issued Urgent Medical Device Recall Notification Letter with a customer response sheet sent to consignees via FedEx on 24-Aug-2018.\nConsignees have been instructed to discard affected product per local and state requirements, or return the affected product to Thermo Fisher Scientific. All consignees are instructed to complete the attached Customer Response Sheet. Thermo Fisher Scientific will issue a no-cost replacement for the recalled product.\nIn addition, consignees are instructed to review results and laboratory reporting associated with use of the affected product for further action. Consignees should notify any personnel who need to be aware of the potential for failure of performance for this product. Questions: contact Technical Services Department at 800-955-6288 Option 2.", "product_quantity": "1329 units", "distribution_pattern": "Nationwide:\nForeign: Argentina\nAustralia\nCanada\nChina\nGreat Britain\nHong Kong\nIndia\nJapan\nMexico\nNetherlands\nNew Zealand\nSingapore\nSouth Korea\nTaiwan", "openfda": { "k_number": [ "K873021", "K883623", "K812617", "K833394", "K832842", "K821915", "K841993", "K861873", "K821912", "K821914", "K870876", "K882780", "K850217", "K810778", "K883140", "K882988", "K883500", "K882986", "K870495", "K832835", "K843043", "K841744", "K820917", "K884031", "K820925", "K871250", "K882844", "K850224", "K851737", "K882860", "K883290", "K883631", "K832690", "K882853", "K882863", "K850522", "K810771", "K850225", "K882864", "K831685", "K843086", "K810780", "K883682", "K852485", "K861870", "K882857", "K821918", "K833392", "K861868", "K820921", "K882787", "K850233", "K882965", "K810783", "K882839", "K873017", "K873013", "K883362", "K833391", "K892938", "K883629", "K812820", "K870494", "K833168", "K882858", "K882777", "K855085", "K882861", "K882778", "K851605", "K873016", "K851607", "K882851", "K882807", "K873093", "K832841", "K883292", "K831686", "K861874", "K873024", "K832839", "K832837", "K873085", "K870480", "K883451", "K872918", "K810776", "K851606", "K820930", "K850227", "K861886", "K834136", "K810784", "K861885", "K883450", "K832838", "K850886", "K832840", "K882842", "K842776", "K850222", "K882845", "K850091", "K850515", "K851863", "K873023", "K882983", "K873091", "K821913", "K882993", "K870499", "K861867", "K882991", "K870529", "K873019", "K810767", "K883287", "K850514", "K845013", "K852602", "K883363", "K882838", "K873095", "K850236", "K861871", "K861869", "K843862", "K820929", "K882850", "K883366", "K883288", "K820918", "K820926", "K861996", "K883367", "K882854", "K844288", "K882846", "K883370", "K883289", "K873094", "K883497", "K842672", "K820919", "K832836", "K834122", "K873018", "K864740", "K850092", "K860282", "K833164", "K883502", "K883628", "K820495", "K833163", "K850922", "K883632", "K883499", "K850218", "K870479", "K810781", "K810773", "K873022", "K850221", "K832930", "K883365", "K803041", "K845014", "K883498", "K821916", "K883364", "K873020", "K850523", "K832689", "K831519", "K850921", "K812531", "K883624", "K850511", "K883625", "K832687", "K882996", "K850513", "K870530", "K850891", "K820914", "K873015", "K850219", "K851604", "K864396", "K843864", "K882837", "K850510", "K883495", "K820924", "K883291", "K861887", "K883445", "K834113", "K882808", "K872465", "K843863", "K870478", "K870481", "K843085", "K810769", "K884572", "K882783", "K883448", "K860783", "K850526", "K843045", "K870496", "K850524", "K882806", "K860623", "K851738", "K852288", "K882859", "K883627", "K890482", "K882995", "K882785", "K851609", "K860788", "K883446", "K882841", "K881000", "K882990", "K883449", "K850525", "K873084", "K832688", "K882862", "K850232", "K883065", "K882866", "K882989", "K870483", "K810770", "K882985", "K870493", "K850229", "K883626", "K860786", "K850890", "K850223", "K883285", "K873014", "K850537", "K873025", "K850990", "K810774", "K834116", "K884574", "K860787", "K850220", "K882847", "K843044", "K870485", "K882786", "K821919", "K850235", "K883951", "K870492", "K833169", "K820508", "K850226", "K870487", "K883368", "K861872", "K852475", "K883501", "K884654", "K850679", "K870490", "K873027", "K820916", "K850089", "K882788", "K890701", "K820509", "K854567", "K882773", "K852568", "K882848", "K833390", "K882779", "K883286", "K860785", "K850512", "K882855", "K882984", "K850516", "K880691", "K883496", "K870451", "K842002", "K883138", "K882865", "K882843", "K831745", "K882856", "K882789", "K873092", "K882987", "K842671", "K850237", "K851608", "K882997", "K870497", "K882775", "K882852", "K820931", "K810768", "K812885", "K882992", "K870498", "K820920", "K851862", "K883139", "K882784", "K850521", "K880999", "K883141", "K861875", "K850517", "K850519", "K883630", "K842775", "K850520", "K845012", "K770764", "K833389", "K882782", "K850228", "K850234", "K863696", "K882774", "K873026", "K833393", "K850230", "K871191", "K883447", "K833165", "K890700", "K884573", "K850518", "K883369", "K882994", "K870489", "K833016", "K810772", "K882840", "K882781", "K850090", "K882790", "K873028", "K821911", "K882849", "K820922", "K821917", "K870488", "K873090", "K820915", "K840744", "K882776" ], "registration_number": [ "3008496303", "3015715780", "3005182159", "2022379", "9614209", "1528450", "3035387168", "3010512490", "3006236690", "1226230", "1048735", "1114298", "3005182157", "3036495174", "3031092085", "3014588186", "3013221738", "3008624479", "3008032237", "3042175767", "3005875593", "3006158025", "1123137", "1318354", "3004107906", "3038430126" ], "fei_number": [ "3008496303", "3015715780", "3005182159", "2022379", "3035387168", "3010512490", "1000123180", "3006236690", "1048735", "3002836339", "1000122536", "1114298", "3005182157", "3036495174", "3031092085", "3014588186", "3013221738", "3008624479", "3008032237", "3042175767", "3005875593", "3006158025", "3002806725", "1318354", "3004107906", "3038430126" ], "device_name": "Media And Components, Synthetic Cell And Tissue Culture", "medical_specialty_description": "Hematology", "regulation_number": "864.2220", "device_class": "1" } } ] }