{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "195406", "product_res_number": "Z-1675-2022", "event_date_initiated": "2022-07-19", "event_date_created": "2022-09-02", "recall_status": "Open, Classified", "res_event_number": "90681", "product_code": "JJE", "k_numbers": [ "K182063" ], "product_description": "VITROS XT 3400 Chemistry System with Version 3.7.2 and below\nProduct Code: 6844458", "code_info": "UDI-DI: 10758750031986\t\n Systems start with 3400XXXX where XXXX is unique for each analyzer", "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": "SAME\n585-453-3000", "reason_for_recall": "Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.", "root_cause_description": "Under Investigation by firm", "action": "Ortho CLinical issued Urgent Medical Device Correction letter on 19 July 2022 to consignees who received a VITROS XT3400 or a VITROS XT7600 System notified via (CL2020-176) of the issue and instructed to:\n\"\tIf your VITROS XT 3400 and/or VITROS XT 7600 Systems require a system shutdown, routine Quality Control processing for MicroSlide assays must be performed per your laboratory procedure, prior to processing patient samples, to determine if the anomaly has occurred.\n\"\tIf QC results are outside your established ranges, Ortho recommends performing a second system shutdown and re-processing QC fluids for those assays that were outside your established ranges. If QC results are still outside established ranges following a second system shutdown, contact Ortho Care\" Technical Solutions Center for guidance.\n\"\tOrtho recommends using the same vial of QC fluids (where possible) throughout these steps to determine if the anomaly has occurred. Refer to the control storage and stability documentation for fluid stability guidelines once opened or reconstituted.\n\"\tPost this notification by each VITROS XT 3400 and/or XT 7600 System until this issue is resolved.\nOrtho is currently investigating this issue; a follow-up communication will be released once our investigation is complete.\n\"\tComplete the enclosed Confirmation of Receipt no later than July 26, 2022.\nIf you have further questions, please contact Ortho Care\" Technical Solutions Center at 1-800-421-3311.", "product_quantity": "506 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.", "openfda": { "k_number": [ "K780464", "K922680", "K840501", "K860021", "K961142", "K924084", "K855196", 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(Photometric, Discrete), For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2160", "device_class": "1" } } ] }