{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73893", "product_res_number": "Z-0580-2009", "event_date_initiated": "2008-09-12", "event_date_posted": "2009-01-12", "recall_status": "Terminated", "event_date_terminated": "2012-04-24", "res_event_number": "49597", "product_code": "JIX", "product_description": "ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04.\n\n\nThe device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples.", "code_info": "Lot Number: 61388M100, 57919M100, 54754M100, and 52632M100.", "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": "626-440-0705", "reason_for_recall": "The field action was initiated after an investigation for the Total Bilirubin reagents (List Number 8G62 and List Number 6L45) determined that the matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the Diazo method. The matrix of this secondary standard caused a positive bias. \n\nBecause of these findings, a new Total Bilirubin calibrator value assignm", "root_cause_description": "Component design/selection", "action": "On September 12, 2008, a Product Correction letter with an attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. The letter instructed customers to take the following actions:\n1. Identify the lot number(s) of Clinical Chemistry Bilirubin Calibrator currently used in your laboratory;\n2. Replace the calibrator value sheet with the appropriate attachment provided with this letter. Discard the previous calibrator value sheet;\n3. Configure the revised Total Bilirubin calibrator values provided in the Attachments, for the appropriate calibrator lot number and reagent list number.\n\nARCHITECT cSystems: Refer to System Configuration in Section 2, Installation Procedures and Special Requirements in the Architect System Operations Manual.\nAEROSET: Refer to Calibrator/Control Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual;\n\n4. Calibrate the Total Bilirubin assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory;\n5. Evaluate your quality control. Shifts in quality control and proficiency testing samples may vary among laboratories and should be evaluated according to your laboratory procedures. NOTE: Refer to the Attachments (E and F) for the representative shift with the revised calibrator values (Patient sample and Control/QC recovery); and\n6. Evaluate your reference range and any shifts in patient results. It is recommended that each laboratory established its own expected ranges, which may be unique to the population it serves.\n\nPlease retain this communication for future reference. If you have forwarded any Clinical Chemistry Bilirubin Calibrator to another laboratory, please provide a copy of this letter to them.\n\nFor questions, please contact ABBOTT Customer Service at 877-422-2688 (or 877-4ABBOTT). Customers outside of the", "product_quantity": "7,101 units worldwide (2,267 units in US).", "distribution_pattern": "Worldwide Distribution including United States, Mexico, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, New Zealand, Bahamas, Guatemala, Argentina, Germany, Thailand, Trinidad/Tobago, Venezuela, Chile, Brazil, El Salvador, Singapore, Australia, Curacao and Cayman Island.", "openfda": { "k_number": [ "K101460", "K841456", "K984014", "K930199", "K897071", "K770142", "K110251", "K800040", "K963533", "K023268", "K030169", "K810964", "K960103", "K873116", "K061390", "K934701", "K030621", "K024305", "K874587", "K871638", "K000576", "K823044", "K871341", "K061750", "K840278", "K984425", "K964527", "K981305", "K904767", "K855014", "K023158", "K051457", "K791956", "K851151", "K042551", "K850405", "K060940", "K033501", "K041905", "K844344", "K881258", "K864909", "K861786", "K133330", "K781757", "K875288", "K041870", "K051619", "K932623", "K141388", "K851990", "K862594", 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