{ "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": "148885", "product_res_number": "Z-0091-2017", "event_date_initiated": "2016-08-11", "event_date_created": "2016-10-17", "recall_status": "Terminated", "event_date_terminated": "2018-06-11", "res_event_number": "74950", "product_code": "CDT", "k_numbers": [ "K130332" ], "product_description": "VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- \nFor in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders", "code_info": "Current/In-date GENs 16, 17, 19, 20, 22, 23, 24, 25, 27 through 32", "firm_fei_number": "1000136573", "recalling_firm": "Ortho-Clinical Diagnostics", "address_1": "100 Indigo Creek Dr", "city": "Rochester", "state": "NY", "postal_code": "14626-5101", "additional_info_contact": "Ms. Jennifer Paine\n908-218-8776", "reason_for_recall": "Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.", "root_cause_description": "Under Investigation by firm", "action": "Ortho-Clinical Diagnostics sent an URGENT PRODUCT CORRECTION Letter (Ref. CL2016-152) dated August 11, 2016 via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all customers who could order and use affected product to inform them that new interferant were identified for GLU, LAC, TRIG and URIC Slides which may cause biased results. Foreign affiliates were informed by e-mail on August 11, 2016, of the issue and instructed to notify their consignees of the issue. For questions, please contact our Ortho CareTM Technical Solutions Center at 1-800-421-3311.\nFor questions regarding this recall call 908-218-8776.", "product_quantity": "US: 60,372 sales units; Foreign: 145,611 sales units", "distribution_pattern": "Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.", "openfda": { "k_number": [ "K832426", "K952741", "K871509", "K812838", "K880238", "K063804", "K802136", "K771608", "K801226", "K860730", "K914018", "K034000", "K792234", "K823709", "K812029", "K760011", "K834518", "K113830", "K771472", "K880628", "K850667", "K823341", "K870012", "K780379", "K150819", "K852010", "K810965", "K861670", "K844032", "K791597", "K780172", "K897159", "K760029", "K862033", "K760713", "K971324", "K863923", "K862706", "K010871", "K993466", "K830288", "K851538", "K863254", "K871508", "K922964", "K771905", "K133067", "K860690", "K770841", "K800301", "K843552", "K960088", "K842443", "K903016", "K915084", "K953971", "K914609", "K781939", "K842891", "K964346", "K843536", "K854182", "K881702", "K893917", "K903897", "K895952", "K910638", "K883405", "K043546", "K874584", "K761262", "K842029", "K771903", "K861793", "K942998", "K897169", "K841062", "K933722", "K850031", "K102993", "K841471", "K821315", "K874187", "K792480", "K931891", "K802256", "K781477", "K854783", "K833082", "K843106", "K832684", "K863075", "K922229", "K854366", "K020488", "K885266", "K801298", "K924710", "K963424", "K923508", "K961477", "K894310", "K971113", "K771904", "K905601", "K771906", "K890337", "K861635", "K924694", "K821205", "K770993", "K812589", "K781466", "K842211", "K871122", "K803091", "K864939", "K791640", "K790773", "K915732", "K832444", "K863874", "K873160", "K843832", "K801891", "K870408", "K130332", "K821875", "K864231", "K800649", "K832871", "K831858", "K771004", "K781240", "K811850", "K870827", "K871301", "K760195", "K961281", "K761200", "K840780", "K873049", "K893973", "K924573", "K812471", "K810680", "K896231", "K855164", "K864268", "K803297", "K854152" ], "registration_number": [ "3006716639", "", "1220972", "2050012", "3004493545", "3012963943", "1616487", "3006305917", "3011989923", "1319681", "3013660430", "3006644620", "9680746", "3014325803", "2050010", "3021010433", "3016438761", "9610126", "2250051", "3005146313", "1063851", "1827821", "3000148879", "2517506", "8020316", "3003795116", "1319809", "2030861", "3003593973", "2029015", "3002642396", "3005333358", "3010825766", "2432235", "2247288", "1181121", "3007662974", "3000308930", "3006198300", "2085064", "9610529", "1832216" ], "fei_number": [ "3006716639", "", "1220972", "1000135102", "2050012", "3004493545", "3012963943", "1616487", "3006305917", "3011989923", "1000160458", "3013660430", "3006644620", "3014325803", "1000305840", "2050010", "3002806560", "3021010433", "3016438761", "2250051", "3002806809", "3005146313", "1827821", "3000148879", "3002806559", "2517506", "3003795116", "1000136573", "3000215862", "3003593973", "3002642396", "1000206808", "3005333358", "3010825766", "2432235", "1181121", "3007662974", "1000442352", "3000308930", "3006198300", "1832216", "1000122044" ], "device_name": "Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1705", "device_class": "1" } } ] }