{ "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": "166207", "product_res_number": "Z-0061-2019", "event_date_initiated": "2018-07-12", "event_date_created": "2018-10-03", "recall_status": "Open, Classified", "res_event_number": "80717", "product_code": "JLW", "k_numbers": [ "K081543" ], "product_description": "VITROS Immunodiagnostic Products - TSH Reagent Pack\n(10758750000227) 1912997", "code_info": "5535 5540 5550 5560 5570 5580 5590 5600 5610 5615 5620 5630 5640 5650 5655 5660 5665 5670 5675 5678 5680 5685 5690", "firm_fei_number": "2250051", "recalling_firm": "Ortho Clinical Diagnostics Inc", "address_1": "1001 US Highway 202", "city": "Raritan", "state": "NJ", "postal_code": "08869-1424", "additional_info_contact": "Mr. Joe Falvo\n585-453-3452", "reason_for_recall": "The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.", "root_cause_description": "Device Design", "action": "On 12 July 2018, a customer letter was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail to all customers who could process the affected products (i.e., VITROS 3600, 5600 and/or ECi/ECiQ Systems) to inform them of the potential interference of biotin at levels lower than stated in the IFUs and that Ortho is in the process of revising the IFUs for the affected products. Ortho recommended customers follow normal laboratory procedures for troubleshooting of samples containing other assay interferences and it was acceptable to continue using the affected products. \n\nIf you have questions, please contact Ortho Care Technical Solutions Center at\n1-800-421-3311.", "product_quantity": "68230", "distribution_pattern": "Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.", "openfda": { "k_number": [ "K141999", "K792562", "K941146", "K792154", "K781170", "K771590", "K931061", "K860054", "K890802", "K951796", "K983442", "K170232", "K903311", "K851329", "K871505", "K934410", "K171103", "K885157", "K854379", "K933212", "K843281", "K990993", "K874061", "K832813", "K153651", "K781150", "K780059", "K900014", "K791855", "K930776", 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