{ "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": "131547", "product_res_number": "Z-0848-2015", "event_date_initiated": "2014-11-06", "event_date_posted": "2014-12-22", "recall_status": "Terminated", "event_date_terminated": "2017-02-28", "res_event_number": "69791", "product_code": "CDT", "k_numbers": [ "K812029" ], "product_description": "VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD \n\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.", "code_info": "Lot 0704-3318-4774 (expiry date 01 Dec 2015)", "firm_fei_number": "1000305840", "recalling_firm": "Ortho-Clinical Diagnostics", "address_1": "513 Technology Blvd", "city": "Rochester", "state": "NY", "postal_code": "14626-3601", "additional_info_contact": "Ms. Jennifer Paine\n908-218-8776", "reason_for_recall": "Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.", "root_cause_description": "Nonconforming Material/Component", "action": "Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated November 6, 2014, via FedEx overnight courierand/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all affected customers. The letter identified the product, the problem, and the acton to be taken by the customer. The letter informed the customers of the issue and advise them to discontinue use of the affected lot and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. For additional questions, please contact OCD's Customer Technical Services at 1-800-421-3311.\nFor questions regarding this recall call 908-218-8776.", "product_quantity": "USA: 380 units, Foreign: 155 units", "distribution_pattern": "Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.", "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" ] } } ] }