{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204984", "product_res_number": "Z-0836-2024", "event_date_initiated": "2023-12-07", "event_date_posted": "2024-01-26", "recall_status": "Open, Classified", "res_event_number": "93625", "product_code": "JOJ", "k_numbers": [ "K191021" ], "product_description": "Terragene Integron IT26-C\n\nTerragene Integron IT26-C with extender\n\nBenco Dental Chemical Integrator [5726-583]\n\nTuttnauer (WTL198-0082)\n\nTerragene Integron (PCD26-C)\n\nTerragene Bionova PCD (PCD222-C)", "code_info": "Product Number: IT26-C\nUDI-DI code: 07798164679622\nLot Numbers:\n19033\n19038\n19039\n19040\n19057\n19105-12\n19105-16\nB10400-13\nB10400-14\nB10400-16\nB10400-21\nB10400-23\n19105-23\n19105-24\nB10519\nB10555\nB10625\nB10627\nB10628\nB10629\nB20040\nB20043\nB30012\nB30013\nB30110\nB30111\nB30112\n\nProduct Number: IT26-C with extender\nUDI-DI code: 07798164678656\nLot Numbers:\n19059\nB10572\nB30068\nB30110\n\nProduct Number: Terragene Integron (PCD26-C)\nUDI-DI code: 07798164679370\nLot Numbers:\n100320\n110320\n220620\nF10009\nF20026\nF20079\nF20084\n\nProduct Number: Benco Dental Chemical Integrator 5726-583\nUDI-DI code: 00366975058768\nLot Numbers:\n131120-8\n131120-1\n131120-2\n131120-4\n131120-7\n131120-5\n131120-11\n131120-3\n131120-16\n131120-15\n131120-12\n131120-19\n131120-10\n131120-6\n131120-18\n131120-17\n131120-14\n131120-13\n131120-9\nB10540\nB20039\nB20185\nB20576\nB30010\nB30138\n\nProduct Number: Tuttnauer (WTL198-0082)\nUDI-DI code: 07798164677888\nLot Numbers:\n120320\n170920-3\n170920-2\n170920-1\n170920-8\n170920-7\n170920-6\n170920-5\n170920-4\nB10331-1\nB10331-2\nB10331-3\nB10539\nB20679", "firm_fei_number": "3013145340", "recalling_firm": "TERRAGENE S.A.", "address_1": "Ruta Nacional N 9, Km 280, Cp 2130 9 parque industrial micropi km 280", "address_2": "Cp 2130", "city": "Alvear", "country": "Argentina", "additional_info_contact": "Customer Service\n844-8377243", "reason_for_recall": "Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.", "root_cause_description": "Labeling False and Misleading", "action": "On 12/07/2023, the firm notified via email its initial importers/distributor a \"Voluntary Recall Notification \" that contained a \"COMMUNICATION TO CUSTOMER VOLUNTARY RECALL OF PRODUCT/URGENT: MEDICAL DEVICE RECALL\" Letter informing them of the discrepancies identified in the IFUs of some products that mentions extended cycles that may mislead users to think that these cycles are part of the FDA-cleared indications for use of the product.\n\nInitial Importers/Distributors are instructed to send the following information to Terragene:\n-Quantity in stock\n-Quantity distributed\n-Consignees\n\nOn or about 12/22/2023, the firm initiated distribution, via email, an \"URGENT: MEDICAL DEVICE RECALL\" Letter to customers (identified by their Initial Imports/Distributors) informing them of the Recall issue (discrepancy identified in the IFU) provide an updated IFU (version 4) correcting the issue. Customers are instructed to print the updated IFU and attach it to their remaining inventory, and to discard the older IFU versions (version 1 thru 3).\n\nFor questions or concerns, contact customer.service@terragene.com or www.terragene.com , or +1-844-837-7243 Monday thru Friday 6:00 AM to 3:00 PM, Eastern Time.", "product_quantity": "36,857 strips", "distribution_pattern": "U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.", "openfda": { "k_number": [ "K802634", "K230558", "K921910", "K992341", "K041017", "K020409", "K972035", "K210553", "K170321", "K150644", "K233187", "K970918", "K813202", "K103053", "K823208", "K101528", "K100891", "K191741", "K212081", "K833264", "K140940", "K991709", "K812856", "K122945", "K052516", "K772135", "K093199", "K191999", "K890758", "K961156", "K203458", "K234084", "K183293", "K243876", "K200096", "K952244", "K922485", "K081600", "K030680", "K241036", "K070419", "K063285", "K102363", "K191236", "K162758", "K233654", 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"regulation_number": "880.2800", "device_class": "2" } } ] }