{ "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": "123985", "product_res_number": "Z-0486-2014", "event_date_initiated": "2013-11-18", "event_date_posted": "2013-12-17", "recall_status": "Terminated", "event_date_terminated": "2015-08-03", "res_event_number": "66886", "product_code": "NBW", "k_numbers": [ "K092602" ], "product_description": "FreeStyle Lite Blood Glucose Test Strips;\r\nFor in vitro diagnostic testing.\r\n50 count; 100 count Product of Ireland;\r\n\r\nUPC 6 99073 70819 9; - 50 count\r\nUPC 6 99073 70822 9 - 50 count\r\nUPC 6 99073 71026 0 - 50 count\r\nUPC 6 99073 70827 4 - 100 count\r\n\r\nManufactured by Abbott Diabetes Care Inc. Alameda, CA.\r\n\r\nThe FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.", "code_info": "Part number: 71026-70;  Lot number: 1281732; Exp. date: 2014/05; Lot number: 1283603; Exp. date: 2014/06;  Part number: 70827-71: Lot number: 1363015, Exp. Date: 2014/11; Lot number: 1363109, Exp. Date 2014/11:  Lot number: 1365921, Exp. Date 2014/12;  Part number 70827-72: Lot number: 1366006 Exp. Date : 2014/12; Lot number 1366111, Exp. Date: 2014/12; Lot number 1366337; Exp. Date: 2014/12; Lot number: 1366515, Exp Date: 2014/12;  Part number 70822-71; Lot number 1283345: Exp. Date: 2014/05; Lot number 1365920; Exp. Date: 2014/12; Lot number 1365934; Exp. Date: 2014/12;  Part number: 70822-72: Lot number: 1350414: Exp Date: 2014/07; Lot number 1363321; Exp. Date 2014/11:  Part number: 70819-70: Lot Number: 1365056: Exp. Date 2014/11; Lot number: 1366347: Exp. Date: 2014/12; Lot number: 1367917; Exp. Date 2014/12 Lot number: 1374907; Exp. Date 2015/03.", "firm_fei_number": "3002803444", "recalling_firm": "Abbott Diabetes Care, Inc.", "address_1": "1360 S Loop Rd", "city": "Alameda", "state": "CA", "postal_code": "94502-7000", "additional_info_contact": "Kelly Duffy\n510-239-2775", "reason_for_recall": "Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.", "root_cause_description": "Other", "action": "Abbott Diabetes Care sent an Urgent Product Recall letter in November 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who were affected were instructed to take the following steps:\r\nCall Abbott Diabetes Care Customers Service immediately at 1-888-736-9869 for replacement of the affected product. \r\nWhile waiting for replacement strips to arrive, use an alternate method to measure their blood glucose.\r\nIf only test strips available to customers were from affected lots, customers should not stop testing their blood glucose. \r\nCustomers were instructed to dispose of the test strips in accordance with their local and state disposal regulations. \r\nCustomers with questions were instructed to call Abbott Diabetes Care Customers Service at 1-888-736-9869.\r\nFor questions regarding this recall call 510-239-2775.\r\nAbbott issued a press release at the request of CDRH on november 27, 2013.", "product_quantity": "141,219 cartons for human use - total", "distribution_pattern": "Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada.\r\n\r\n**Center Recommended Depth - Consumers/User**", "openfda": { "k_number": [ "K130138", "K172723", "K222234", "K123935", "K040848", "K081715", "K090057", "K170064", "K120558", "K090188", "K133522", "K062770", "K223722", "K153286", "K091898", "K181316", "K123089", "K170267", "K052208", "K080538", "K043340", "K021513", "K120568", "K090405", "K030703", "K150214", "K160742", "K160365", "K201037", "K121133", "K061118", "K081703", "K011738", "K133741", "K092902", "K072543", "K123136", "K082201", "K102678", "K070472", "K112738", "K123559", "K073118", "K052108", "K042005", "K150274", "K230625", "K123517", "K112275", "K132633", "K081451", "K010553", "K151265", "K171941", "K063068", "K071393", "K051213", "K163087", "K051854", "K112963", "K070017", "K231476", "K122338", "K150833", "K142928", "K012975", "K023584", "K051839", "K081957", 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