{ "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": "122064", "product_res_number": "Z-0178-2014", "event_date_initiated": "2013-09-04", "event_date_posted": "2013-11-07", "recall_status": "Terminated", "event_date_terminated": "2013-12-12", "res_event_number": "66331", "product_code": "CJY", "k_numbers": [ "K110830" ], "product_description": "Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. \r\n\r\nThe kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. \r\nThe vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, .\r\n\r\nCALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.", "code_info": "Lot numbers distributed in the US:  Lot 11-2614, Expiration 07/2013. Lot 12-1002; Expiration 03/2014. Lot 12-2220, Expiration 08/2014.  Lot numbers distributed in Sweden: 11-2129, 12-2616, 11-2769, 12-2975, 10-3036, 10-0454, 10-1874, 11-0176, 11-1248, 11-1690, 12-0140, 12-0938, 12-1383, 13-0004, and 13-0408", "firm_fei_number": "3007662974", "recalling_firm": "SEPPIM SAS", "address_1": "ZONE INDUSTRIELLE", "city": "SEES", "country": "France", "additional_info_contact": "855-354-8324", "reason_for_recall": "Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.", "root_cause_description": "Device Design", "action": "ELITech Group of Bothell, WA sent an Urgent: Product Recall Notice dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. \r\n\r\nActions to be taken:\r\n\r\n\" Laboratories must not use plasma for the determination of total calcium when using this product. The product can still be used to determine total calcium with serum sample.\r\n\r\n\" ELITech Clinical Systems SAS has revised the package insert and kit box label for the CALCIUM ARSENAZO reagent reference CALA-0250. All mentions of the use of the plasma will be removed from the documentation. If you have inventory of CALCIUM ARSENAZO, reference CALA- 0250. All lots. in your laboratory, please discard the insert that you have and replace it with the insert enclosed with this notice.\r\n\r\n\" If you have transferred any of this product to another location, please forward a copy this bulletin to that location.\r\n\r\n\" All users receive CALCIUM ARSENAZO, CALA-0250, from distributors. To be certain everyone who is possibly affected by this change is contacted, we are sending this communication to all registered users. As confirmation of receipt of this notice, please return the attached receipt confirmation to Technical Support by fax (401-642-9003) within 48 hours of receipt.\r\n\r\nWe apologize for the inconvenience that this situation can cause in your laboratories; we remain at your disposal for further information. If you have any questions, please contact Technical Support at 1-855-ELITECH (855-354-324)\r\n\r\nWe thank you for your cooperation and the attention which you will give to this bulletin.", "product_quantity": "47 kits in US and 48 kits in Sweden", "distribution_pattern": "Worldwide Distribution - US including the states of KY and UT and the country of Sweden.", "openfda": { "k_number": [ "K880576", "K880949", "K981578", "K922835", "K963536", "K894204", "K182042", "K073355", "K244042", "K883453", "K895873", "K974607", "K761029", "K770817", "K061575", "K072356", "K072440", "K890584", "K813040", "K123171", "K021334", "K933678", "K941764", "K022049", "K191396", "K902476", "K771928", "K083386", "K953395", "K011441", "K880242", "K891061", "K900231", "K051757", "K151113", "K062855", "K961226", "K983789", "K981794", "K944255", "K981232", "K894476", "K982035", "K890302", "K072443", "K120626", "K040972" ], "device_name": "Azo Dye, Calcium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1145", "device_class": "2", "registration_number": [ "2432235", "1319809", "1220972", "1319808", "2050012", "3006716639", "3002642396", "2032112", "1616487", "3011989923", "2939693", "3007662974", "2085064", "1181121", "2250051", "9680746", "2247288", "3016438761", "3000308930", "3000148879", "1319681", "3003593973", "3005333358", "2050010", "3012963943", "2030861", "3004493545", "8020316", "8040374" ], "fei_number": [ "2432235", "1220972", "3003076831", "1000206808", "3002806809", "2050012", "3006716639", "3002642396", "3000215862", "1616487", "3011989923", "2939693", "3007662974", "1000135102", "1181121", "2250051", "5864", "1000136573", "3016438761", "1000305841", "1000305840", "3000308930", "3000148879", "3003593973", "3005333358", "2050010", "1000122044", "3012963943", "3004493545" ] } } ] }