{ "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": "95633", "product_res_number": "Z-0711-2011", "event_date_initiated": "2010-11-10", "event_date_posted": "2010-12-16", "recall_status": "Terminated", "event_date_terminated": "2011-09-19", "res_event_number": "57230", "product_code": "CHH", "k_numbers": [ "K842160" ], "product_description": "Genzyme Diagnostics Total Serum Cholesterol Kit, IVD\nCatalog Number: 225-26\nIntended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.", "code_info": "Lot 37772  Exp. Date: May 2011", "firm_fei_number": "3002806809", "recalling_firm": "Diagnostic Chemicals, Ltd.", "address_1": "16 McCarville Street", "city": "Charlottetown", "country": "Canada", "reason_for_recall": "Cholesterol Reagent bottles labels reversed for R1 and R2", "root_cause_description": "Labeling mix-ups", "action": "Genzyme Diagnostics P.E.I. Inc. sent an \"IMPORTANT PRODUCT FIELD CORRECTION\" letter dated November 10, 2010, via Federal Express to customers. The letter described the label error and requested that the reagents not be interchanged with another reagent lot. The firm ask that the customers complete and return the attached IMPORTANT PRODUCT FIELD CORRECTION confirmation of notification via fax at 902-628-6504. \n\nContact a Genzyme Diagnostics Technical Services Representative at 1-800-\n565-0265, if you require further information, or if you have any questions.", "product_quantity": "30 kits", "distribution_pattern": "Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.", "openfda": { "k_number": [ "K780783", "K013173", "K855028", "K914160", "K031824", "K770265", "K992803", "K853854", "K820950", "K900850", "K864081", "K910240", "K875131", "K840189", "K820951", "K923128", "K770747", "K062026", "K800457", "K890267", "K863062", "K780389", "K904031", "K844242", "K895951", "K113262", "K902098", "K934046", "K852009", "K151545", "K023558", "K232404", "K810405", "K810673", "K912212", "K812091", "K832158", "K863927", "K863252", "K790724", "K840368", "K790768", "K950164", "K130200", "K852863", "K911692", 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