{ "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": "115401", "product_res_number": "Z-0793-2013", "event_date_initiated": "2012-12-21", "event_date_posted": "2013-02-07", "recall_status": "Terminated", "event_date_terminated": "2013-05-16", "res_event_number": "64132", "product_code": "DHB", "k_numbers": [ "K051677" ], "product_description": "OPTIGEN Food 30; Catalog number: 85035. For allergen testing. \r\n\r\nManufactured by Hitachi Chemical Diagnostics, Mountain View, CA.\r\nDistributed by Theridiag, Cedex, France", "code_info": "Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.", "firm_fei_number": "2936856", "recalling_firm": "Hitachi Chemical Diagnostics Inc", "address_1": "630 Clyde Ct", "city": "Mountain View", "state": "CA", "postal_code": "94043-2239", "additional_info_contact": "Lisa Charter\n650-961-5501", "reason_for_recall": "There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.", "root_cause_description": "Process control", "action": "Hitachi sent an Urgent Product Recall Notification letter dated December 21, 2012, to the affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was instructed to discontinue distribution and destroy any remaining inventory of the affected product at their location per their local waste ordinances, determine if any of their customers are using or have inventory of the affected product, rquest that their customers review all patient results reported with the use of the affectted product. The customer was instructed to tell their customers to discontinue use and destroy any remaining inventory per their local waste ordinances. The customer was instructed to retain a copy of the notification letter for their records. The customer was also instructed to send confirmation of the destruction within 5 days \r\nCustomers were instructed to complete and return the attached Certificate of Destruction. For questions customers were instructed to contact their local area Customer Service.\r\nFor questions regarding this recall 650-961-5501.", "product_quantity": "20 kits", "distribution_pattern": "Worldwide Distribution - France only", "openfda": { "k_number": [ "K863844", "K862176", "K873486", "K935876", "K874169", "K182479", "K873770", "K242531", "K823593", "K862264", "K924209", "K896902", "K953780", "K832217", "K260591", "K843694", "K121156", "K151029", "K873406", "K891135", "K880001", "K872280", "K941278", "K864104", "K945748", "K101251", "K962274", "K840537", "K851273", "K831554", "K880547", "K913892", "K083314", "K962976", "K173726", "K013135", "K802556", "K904661", "K830155", "K830170", "K965094", "K912294", "K862938", "K923420", "K924044", "K972068", "K871660", "K021208", "K871684", "K860027", "K904330", "K260280", "K051218", "K091289", "K850895", "K926420", "K941057", "K112523", "K875163", "K874717", "K893132", "K830096", "K831091", "K100999", "K910075", "K191510", "K874446", "K123275", "K831045", "K131738", "K862173", "K091984", "K852794", "K870625", "K851512", "K925044", "K894227", "K922538", "K090257", "K261027", "K193613", "K884923", "K873969", "K252775", "K823470", "K905176", "K873814", "K931746", "K861184", "K100910", "K914685", "K112910", "K943768", "K121463", "K903637", "K845032", "K954566", "K853456", "K913150", "K822141", "K113841", "K896694", "K842457", "K953014", "K863098", "K834598", "K941993", "K871599", "K875168", "K883537", "K132801", "K872946", "K870966", "K913833", "K200825", "K023152", "K883371", "K883273", "K874540", "K905054", "K885269", "K854865", "K934524", "K914554", "K000132", "K870597", "K871331", "K875329", "K874440", "K982343", "K913212", "K771578", "K880002", "K875125", "K863973", "K880221", "K092050", "K935488", "K840670", "K863743", "K122197", "K021206", "K862266", "K880160", "K910292", "K911903", "K212181", "K983954", "K875244", "K852263", "K863794", "K862265", "K820029", "K190315", "K880168", "K880899", "K921574", "K810462", "K950728", "K081217", "K823592", "K875274", "K881899", "K961889", "K150597", "K972364", "K874281", "K875110", "K896592", "K853969", "K863967", "K885065", "K862901", "K870264", "K923284", "K092978", "K874883", "K870152", "K884501", "K111919", "K863355", "K880003", "K896852", "K854939", "K875066", "K873193", "K840876", "K071913", "K873648", "K080322", "K884883", "K093107", "K874150", "K163370", "K852189", "K950629", "K871723", "K884185", "K883666", "K013134", "K831442", "K875328", "K905636", "K200279", "K892409", "K093987", "K880415", "K902576", "K894190", "K991048", "K252493", "K864696", "K912582", "K924119", "K925425", "K083853", "K910517", "K150854", "K914959", "K974580", "K051677", "K260059", "K941564", "K855053", "K870624", "K834526", "K833885", "K220162", "K880567", "K914850", "K894253", "K873998", "K841516", "K973186", "K832344", "K182793", "K870153", "K993388", "K874168", "K863123", "K812414", "K840360", "K974350", "K081830", "K863394", "K874149", "K963245", "K874802", "K030590", "K821451", "K854756", "K844629", "K020387", "K833418", "K873676", "K897145", "K883616", "K863036", "K905162", "K862175", "K843302", "K870009", "K862939", "K101572", "K903742", "K873112", "K880187", "K945884" ], "registration_number": [ "3004973408", "3006198300", "1036362", "2016473", "3002806944", "2517506", "2432235", "3013521527", "3039353646", "9610865", "3003477135", "9610566", "2029275", "1423662", "3031570369", "2936856", "2022994" ], "fei_number": [ "3002807876", "3004973408", "3006198300", "1036362", "3002806350", "3002806944", "1000306431", "2517506", "3013521527", "2432235", "3039353646", "3003477135", "1000125787", "3000215273", "3031570369", "2936856", "2022994" ], "device_name": "System, Test, Radioallergosorbent (Rast) Immunological", "medical_specialty_description": "Immunology", "regulation_number": "866.5750", "device_class": "2" } } ] }