{ "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": "65278", "product_res_number": "Z-0288-2008", "event_date_initiated": "2007-08-10", "event_date_created": "2015-06-25", "recall_status": "Terminated", "event_date_terminated": "2012-04-19", "res_event_number": "45333", "product_code": "JIX", "k_numbers": [ "K981706" ], "product_description": "Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064", "code_info": "List Number (LN) 1E66-03 Lot Number: 38436M100 (Expires September 30, 2007); List Number (LN) 1E66-04 Lot Numbers: 41456M100 (Expires December 31, 2007), 42396M100 (Expires April 30, 2008), 48616M100 (Expires July 31, 2007)", "firm_fei_number": "2018433", "recalling_firm": "Abbott Laboratories Inc.", "address_1": "820 Mission St", "city": "South Pasadena", "state": "CA", "postal_code": "91030-3142", "additional_info_contact": "Mark Littlefield\n972-518-6062", "reason_for_recall": "Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.", "root_cause_description": "Material/Component Contamination", "action": "An August 10, 2007, Product Correction letter was provided to all ARCHITECT cSystem and AEROSET System customers. The letter advises that changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the NIST standard 916a. Revised Bilirubin values for the calibrator lot numbers in this recall are attached to the recall notice. Six necessary actions were listed in the recall notice as: 1) Identify the lot numbers of Clinical Chemistry Bilirubin Calibrator(s) currently in use. 2) Discard the value sheet and replace with the appropriate values provided with the recall letter. 3) Enter the revised Bilirubin values. 4) Calibrate the assays. 5) Evaluate your quality control. 6) Evaluate your reference range and any shifts in patient results.", "product_quantity": "7,033 units total worldwide", "distribution_pattern": "Worldwide: USA, Canada, Mexico, Guatemala, Puerto Rico, Germany, Hong Kong, Singapore, Australia, New Zealand, Jamaica, Venezuela, Columbia, Ecuador, Chile, Uruguay, Argentina, Brazil, Thailand, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, and El Salvador", "openfda": { "k_number": [ "K933955", "K062035", "K992086", "K023876", "K930231", "K855014", "K844344", "K974290", "K061923", "K983469", "K854092", "K791956", "K822937", "K934607", "K914917", "K012470", "K062055", "K882258", "K161140", 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