{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "142863", "product_res_number": "Z-0742-2016", "event_date_initiated": "2016-01-11", "event_date_posted": "2016-02-02", "recall_status": "Terminated", "event_date_terminated": "2016-06-07", "res_event_number": "73033", "product_code": "CDT", "k_numbers": [ "K060854" ], "product_description": "ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.", "code_info": "All Lots", "firm_fei_number": "3002698356", "recalling_firm": "Horiba Instruments Inc", "address_1": "9755 Research Dr", "city": "Irvine", "state": "CA", "postal_code": "92618-4626", "additional_info_contact": "949-250-4811", "reason_for_recall": "N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.", "root_cause_description": "Under Investigation by firm", "action": "Customer notification letters were sent on 01/11/16.\n\nCustomers were provided the following instructions/actions:\nWhen performing tests that use the Tinder reaction, the blood draw should be done before treatment is given to the patient.\n\nReagent inserts for the concerned HORIBA Medical Products have been updated and now include the following additional warning:\nPatients treated with N-Acetylcysteine (NAC) for Paracetamol overdose may generate a false low result.\n\nThe letter request customers share the information with laboratory staff and retain the notification as part of their laboratory documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days in order for the firm to verify the understanding of the notice.\n\nIf any questions contact the local HORIBA Medical representative.", "product_quantity": "216", "distribution_pattern": "U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN\n\nNo foreign distribution.", "openfda": { "k_number": [ "K850031", "K961477", "K850667", "K770841", "K922964", "K873160", "K863923", "K862706", "K961281", "K812838", "K885266", "K870012", "K864268", "K812471", "K792480", "K840780", "K860690", "K810965", "K842891", "K800649", "K894310", "K963424", "K812029", "K924710", "K861635", "K905601", "K890337", "K874187", "K771905", "K780172", "K993466", "K880238", "K801891", "K150819", "K832871", "K874584", "K854366", "K780379", "K761262", "K842443", "K953971", "K821205", "K063804", "K852010", "K851538", "K803091", "K810680", "K871122", "K102993", "K863874", "K812589", "K914609", "K960088", "K801226", "K834518", "K854152", "K896231", "K760029", "K871301", "K781466", "K760713", "K844032", "K821875", "K843552", "K010871", "K771004", "K800301", "K760195", "K791597", "K811850", "K854783", "K832426", "K020488", "K770993", "K952741", "K043546", "K843832", "K855164", "K893973", "K802256", "K781240", "K915732", "K831858", "K924694", "K842029", "K864231", "K914018", "K862033", "K873049", "K861793", "K871509", "K830288", "K860730", "K034000", "K841471", "K843536", "K823709", "K781939", "K910638", "K130332", "K791640", "K883405", "K781477", "K871508", "K863075", "K861670", "K893917", "K802136", "K832444", "K924573", "K897159", "K133067", "K771903", "K821315", "K931891", "K964346", "K760011", "K864939", "K801298", "K771472", "K915084", "K880628", "K923508", "K771906", "K792234", "K863254", "K881702", "K843106", "K841062", "K903897", "K823341", "K897169", "K832684", "K771904", "K771608", "K933722", "K833082", "K971113", "K842211", "K870408", "K903016", "K113830", "K942998", "K790773", "K803297", "K971324", "K870827", "K761200", "K895952", "K854182", "K922229" ], "device_name": "Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1705", "device_class": "1", "registration_number": [ "", "2432235", "1319809", "2029015", "1220972", "2050012", "3006644620", "3006716639", "3013660430", "1827821", "3002642396", "3006198300", "1616487", "3011989923", "1063851", "9610126", "3007662974", "3021010433", "2085064", "1181121", "2250051", "9680746", "2517506", "2247288", "3016438761", "3005146313", "1832216", "3000308930", "3000148879", "1319681", "3003593973", "3005333358", "2050010", "3014325803", "3012963943", "2030861", "3004493545", "8020316", "9610529", "3010825766", "3003795116", "3006305917" ], "fei_number": [ "1000160458", "", "2432235", "3002806559", "1220972", "1000206808", "3002806809", "2050012", "3006644620", "3006716639", "3013660430", "1827821", "3002642396", "3006198300", "3000215862", "1616487", "3011989923", "3007662974", "3021010433", "3002806560", "1000135102", "1181121", "2250051", "1000136573", "2517506", "3016438761", "3005146313", "1832216", "1000305840", "3000308930", "3000148879", "3003593973", "3005333358", "2050010", "1000122044", "3014325803", "3012963943", "3004493545", "3010825766", "1000442352", "3003795116", "3006305917" ] } } ] }