{ "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": "169364", "product_res_number": "Z-0660-2019", "event_date_initiated": "2018-11-19", "event_date_created": "2018-12-21", "recall_status": "Terminated", "event_date_terminated": "2020-04-23", "res_event_number": "81664", "product_code": "JIX", "k_numbers": [ "K031608" ], "product_description": "SP CAL (LIQ), REF IT2692\n\n This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.", "code_info": "05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019", "firm_fei_number": "1000361607", "recalling_firm": "Randox Laboratories Ltd.", "address_1": "55 Diamond Road", "city": "Crumlin", "state": "North", "country": "Ireland", "reason_for_recall": "Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.", "root_cause_description": "Under Investigation by firm", "action": "On November 19, 2018, Randox Laboratories Ltd. issued \"Urgent Medical Device Correction\" notices and New Calibrator Value sheets (Revised 15 Nov 18 pl) to customers. \nCustomers were advised to take the following action:\n- Review all remaining stock. Add the notice and replace the calibrator value sheet with the revised document provided.\n- Discuss the contents of the notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient. \n- Retain a copy of the letter with laboratory records and forward a copy of the letter to those who may have received this product.\n- Return the completed response form via email to technical.services@randox.com.\n\nIf you have any questions, contact RA Specialist by email at maria.kelly@randox.com.", "product_quantity": "250 kits (32 kits US / 218 kits OUS)", "distribution_pattern": "US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.", "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", 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