{ "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": "190719", "product_res_number": "Z-0503-2022", "event_date_initiated": "2021-11-22", "event_date_created": "2022-01-18", "recall_status": "Open, Classified", "res_event_number": "89183", "product_code": "PPM", "product_description": "VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack", "code_info": "Lot # 2190;\nProduct code(unique Device Identifier): 8430373\n(10758750004898)", "firm_fei_number": "1000136573", "recalling_firm": "Ortho-Clinical Diagnostics, Inc.", "address_1": "100 Indigo Creek Dr", "city": "Rochester", "state": "NY", "postal_code": "14626-5101", "additional_info_contact": "Mr. Joe Falvo\n585-453-3000", "reason_for_recall": "Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.", "root_cause_description": "Under Investigation by firm", "action": "Ortho clinical Diagnostics issued an Important product correction notification on November 22, 2021. \n\nActions to be taken by the Distributors:\n1. Please provide the communication (Ref. CL2021-287) to customers who were shipped VITROS HSDA Lot 2190 from your facility.\n2. Do not continue to distribute VITROS HSDA Lot 2190.\n3. Complete the Confirmation of Receipt form no later than November 30, 2021.\n4. Please forward this notification if the product was distributed outside of your facility.\n\nIf you have questions, please contact our Ortho Care\" Technical Solutions Center at 1-800-421-3311.\n\nAction to be taken by the customers:\n1. Discontinue using VITROS HSDA Lot 2190 if your laboratory utilizes VITROS TSH Reagent Pack.\n2.Complete the Confirmation of Receipt form no later than November 30, 2021, even if no replacement product is required. If replacement is required, indicate the quantity of VITROS HSDA Lot 2190 to be replaced.\n3. Please forward this notification if the product was distributed outside of your facility.\nContact Information\n\nIf you have further questions, please contact Ortho Care\" Technical Solutions Center at 1-800-421-3311", "product_quantity": "1416 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.", "openfda": { "k_number": [ "K863550", "K842863", "K831619", "K842070", "K811800", "K850845", "K850916", "K811796", "K831620", "K842729", "K850737", "K871533", "K861890", "K842934", "K822326", "K822037" ], "registration_number": [ "3010692993", "3009161685", "3038196622", "2432235", 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