{ "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": "140259", "product_res_number": "Z-0231-2016", "event_date_initiated": "2015-09-10", "event_date_posted": "2015-11-05", "recall_status": "Terminated", "event_date_terminated": "2018-05-29", "res_event_number": "72220", "product_code": "JJE", "k_numbers": [ "K031924", "K063144" ], "product_description": "VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest.", "code_info": "Software Versions 2.2.1 through 2.8; Catalog # 6801375 Serial Numbers: 34000119 through 34002323; Catalog # 6801890 Serial Numbers: J34000133, J34000193, J34000197, J34000212, J34000285, J34000316, J34000318, J34000337, J34000360, J34000420, J34000451, J34000478, J34000495, J34000497, J34000529, J34000538, J34000552, J34000557, J34000590, J34000596, J34000601, J34000631, J34000642, J34000761, J34000799, J34000805, J34000833, J34000851, J34000893, J34000946, J34000947, J34001006, J34001172, J34001218, J34001240, J34001243, J34001248, J34001251, J34001274, J34001297, J34001311, J34001317, J34001345, J34001378, J34001379, J34001389, J34001390, J34001396, J34001422, J34001472, J34001504, J34001569, J34001572, J34001612, J34001626, J34001633, J34001668, J34001755, J34001809, J34001840, J34001850, J34001875, J34001897.", "firm_fei_number": "1000136573", "recalling_firm": "Ortho-Clinical Diagnostics", "address_1": "100 Indigo Creek Dr", "city": "Rochester", "state": "NY", "postal_code": "14626-5101", "reason_for_recall": "Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters would not be saved as expected, but remained changed to the default values obtained from the ADD disk.", "root_cause_description": "Software design", "action": "The firm, Ortho Clinical Diagnostics, sent a \"FOLLOW UP to URGENT PRODUCT CORRECTION NOTIFICATION\" letter dated 9/10/2015 and response forms to customers via FedEx overnight courier, e-mail (ORTHO PLUS e-Communications) and/or via US Postal Service overnight letter on 9/10/2015. Foreign affiliates were informed by email on 9/10/2015 of the issue and instructed to notify their consignees of the issue and required actions.\r\nThe letter described the product, problem, and actions to be taken. The customers were instructed to follow the required actions and complete and return the Confirmation of Receipt-Response Required form, no later\r\nthan 9/18/15, by fax at 1.888.557.3759 or 1.585.453.4110, or scan PDF and email to: ConfirmationAdmin@its.jnj.com. Customers with any additional questions, can contact Customer Technical Services at 1-800-421-3311 at any time.", "product_quantity": "Catalog # 6801375: Domestic 919; Foreign 1251; Catalog 6801890: Domestic 63, Foreign 147", "distribution_pattern": "Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.", "openfda": { "k_number": [ "K130915", "K946090", "K833067", "K920402", "K904219", "K830212", "K945271", "K831477", "K843059", "K945135", "K790072", "K883209", "K073370", "K772319", "K910185", "K961481", "K830762", "K063144", "K040958", "K922139", "K800085", "K852133", "K832584", "K890184", "K843283", "K870833", "K893776", "K771245", "K840501", "K842500", "K811194", "K922680", "K782014", "K945566", "K853391", "K890927", "K841916", "K854243", "K771345", "K872105", "K962235", "K883533", "K781076", 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