{ "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": "190239", "product_res_number": "Z-0328-2022", "event_date_initiated": "2021-11-01", "event_date_created": "2021-12-01", "recall_status": "Terminated", "event_date_terminated": "2023-03-09", "res_event_number": "88999", "product_code": "CHH", "k_numbers": [ "K923504" ], "product_description": "RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum\nREF: CH200", "code_info": "Lot Numbers/Exp Date:\n559344 28th June 2022;\n572730 28th July 2023.\nGTIN: 05055273201130", "firm_fei_number": "1000361607", "recalling_firm": "Randox Laboratories Ltd.", "address_1": "55 Diamond Road", "city": "Crumlin", "state": "North", "country": "Ireland", "reason_for_recall": "When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range", "root_cause_description": "Under Investigation by firm", "action": "Randox USA, Distributor contacted the customer via Urgent Medical Device Correction letter email on 11/1/21. The letter states reason for recall, health risk and action to take:\nAction to be taken:\n\" Discontinue use of and discard any of the above batches immediately.\n\" Review your reagent inventory of these products and assess your laboratories needs\nfor reimbursement for discarded inventory.\n\" Review results generated with the affected batches in line with the clinical profile of\nthe patient.\n\" Discuss the contents of this notice with your Medical Director.\n\" Complete and return the response form 12187-QA to technical.services@randox.com\nwithin five working days.\nTransmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation.\nIf you have any questions or concerns please contact Randox Technical Services.", "product_quantity": "15 kits", "distribution_pattern": "US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.", "openfda": { "k_number": [ "K971072", "K913565", 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