{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194410", "product_res_number": "Z-1384-2022", "event_date_initiated": "2022-05-20", "event_date_created": "2022-07-14", "recall_status": "Open, Classified", "res_event_number": "90435", "product_code": "PPM", "product_description": "Kit Label:\nAnti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2\nAnti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21\n\nVial Labels:\nMat. No K589911-21512", "code_info": "Kit Model Number: K589911-2\nUDI-DI Code for Kit: 0 5700571 11286 1\nLot Numbers:\n06586309;\n06646626;\n\nVial Material Number:\nK859911-21512\nLot Number: 06646739\nLot Number: 06586327", "firm_fei_number": "2916205", "recalling_firm": "Agilent Technologies, Inc.", "address_1": "5301 Stevens Creek Blvd", "city": "Santa Clara", "state": "CA", "postal_code": "95051-7201", "additional_info_contact": "Sarah Litton\n669-255-7696", "reason_for_recall": "Label provided for substrate vail contained incorrect expiration date.", "root_cause_description": "Labeling Change Control", "action": "On 05/20/2022 and 05/27/2022, Agilent Technologies, Inc. had conference calls with the two Medical Laboratory Facilities that were distributed the affected product to inform them of the situation of the incorrect expiration date on the substrate vials (incorrect expiration dated of 6-30-22. The correct expiration date should be 4-30-22\n\nCustomer are instructed/informed:\n- To immediately cease using Anti-FITC-AP CISH Accessory Kit Lot Numbers 06586309 and 06646626, and to return any remaining labels to Agilent, and return any unused kits to Agilent.\n- That Agilent is completing production of a new lot of the Kit, and will be shipping to customers on Monday, 05/23/2022, to replace those expired kits. Kits will be provided Free of Charge.\n- To review test data/results from 05/01/2022 onwards as appropriate in accordance with their applicable procedures.\n\nOn 06/10/2022, an \"Urgent Product Removal\" letter was emailed to customer informing them of the removal action.\n\nFor any questions or further assistance, contact Agilent's Field Action Team at fieldactions@agilent.com", "product_quantity": "63 kits", "distribution_pattern": "U.S. Nationwide distribution in the states of NY and VA.", "openfda": { "k_number": [ "K822326", "K842934", "K850737", "K831620", "K871533", "K822037", "K842070", "K811800", "K850916", "K811796", "K863550", "K831619", "K850845", "K861890", "K842729", "K842863" ], "registration_number": [ "2032839", "9710337", "2242436", "3010421384", "1649339", "3002444944", "2050012", "3005181013", "3003742580", "9614373", "3044778371", "8030124", "2150138", "3030446844", "3002642396", "9710666", "1000391282", "9615056", "8043909", "2250051", "3008352382", "3010324880", 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