{ "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": "167125", "product_res_number": "Z-0079-2019", "event_date_initiated": "2018-08-15", "event_date_created": "2018-10-05", "recall_status": "Terminated", "event_date_terminated": "2022-01-10", "res_event_number": "80959", "product_code": "JLW", "k_numbers": [ "K081543" ], "product_description": "VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,\nCatalog Number: 6802413", "code_info": "Serial Numbers : J56000024 through J56003300", "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": "Joe Falvo\n585-453-3452", "reason_for_recall": "Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.", "root_cause_description": "Software design", "action": "ORTHO PLUSSM is e-Communications, a service that provides subscribing customers with Ortho Clinical Diagnostics (Ortho) product notifications electronically on 15 August 2018, a customer letter (Ref. CL2018-174) was sent 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 received VITROS 5600 Integrated Systems to inform them of the potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. Ortho also provided specific actions for customers to take when they observe unexpected MicroSlide assay results for a sample associated with TE1-504 and/or TE1-594 condition codes. Customers were also instructed to discuss any concerns related to this issue and previously reported results with the Laboratory Medical Director.", "product_quantity": "U.S.= 1255\tex-U.S.= 1504", "distribution_pattern": "Nationwide\nForeign: France, Brazil, Chile, Great Britain, Phillippines, Spain", "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", "K830036", "K760801", "K771222", "K781296", "K922736", "K952148", "K801691", "K063437", "K890579", "K800798", "K222116", "K760132", "K852438", "K083844", "K935119", "K870320", "K843395", "K811431", "K843545", "K910411", "K870244", "K881443", "K910837", "K873303", "K081074", "K771767", "K772192", "K081543", "K023093", "K905710", 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