{ "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": "39361", "product_res_number": "Z-0887-05", "event_date_initiated": "2003-11-17", "event_date_posted": "2005-06-14", "recall_status": "Terminated", "event_date_terminated": "2005-09-20", "res_event_number": "32200", "product_code": "CGA", "k_numbers": [ "K024194" ], "product_description": "LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., \n1000 Gibraltar Drive, Milpitas, CA 95037", "code_info": "OneTouch Ultra Test Strip Lot: 1022859; [A second lot (# 1022865) was also mislabeled with the incorrect Control Solution range. This lot was distributed outside of the US, exclusively in Italy.]", "firm_fei_number": "2939301", "recalling_firm": "Lifescan Inc", "address_1": "1000 Gibraltar Dr", "city": "Milpitas", "state": "CA", "postal_code": "95035-6301", "additional_info_contact": "Mario Lowe\n408-956-4087", "reason_for_recall": "A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.", "root_cause_description": "Other", "action": "On 11/17/03 the firm initiated the recall and their notification was via letters informing its customers of the removal.", "product_quantity": "8,718 boxes (containing 435,900 test strips)", "distribution_pattern": "Product was released for distribution to 30 consignees nationwide.\n\nThe firm provided the following distribution information: 6 wholesaler dealers, 20 distributors, 3 retailers and one (1) consumers/users involved in the recall.\nNote: This customer received a shipment of 2 Test Strip boxes (2 boxes x 50 strips/box = 100 test strips) as 'free goods' and was most likely for an LifeScan employee in the field.\n\nThe lot was released from LifeScan's facility in Puerto Rico on May 1, 2003 and received at LifeScan's warehouse in Milpitas, CA on May 16, 2003. From the Milpitas warehouse, this lot was transferred to LifeScan's warehouse in Mechanicsburg, PA where it was received on June 16, 2003. The affected lot was distributed out of the Mechanicsburg, PA warehouse only.\n\nThe recall product was distributed in the U.S. only, to the following states: AL, DE, FL, IL, IN, MA, MI, MN, MO, NC, NH, NJ, OH, PA, TN, TX, VA and WV.\n\n(A second lot was also mislabeled with the incorrect Control Solution range. This lot was manufactured outside of the US and distributed exclusively in Italy.)\n\nThe total number of government sales/distribution centers that received the recall product = 0.", "openfda": { "k_number": [ "K003346", "K024014", "K936212", "K771754", "K915772", "K781307", "K000365", "K913357", "K002688", "K962295", "K884909", "K002621", "K813168", "K811882", "K822976", "K911141", "K082965", "K923048", "K761153", "K210958", "K973140", "K103842", "K842393", "K960034", "K761060", "K963535", "K950628", "K041478", "K073416", "K890336", "K971812", "K990649", "K001427", "K081714", "K813370", "K760347", "K822958", "K993837", "K903191", "K091102", "K120448", "K993632", "K831194", "K801663", "K880703", "K070057", "K880585", "K855194", "K960337", "K854177", "K041427", "K093506", "K103195", "K103278", "K801897", "K851703", "K925551", "K053079", "K062799", "K771000", "K001092", "K791685", "K842221", "K020232", "K851618", "K014139", "K943432", "K982076", "K093941", "K862721", "K960053", 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"3003166194", "1825396", "1827821", "2431530", "3008959428", "3003366417", "3009473156", "3043013796", "3008789114", "3013513377", "1000136573", "3024512705", "1217183", "3042301847", "3015058854", "3003422726", "3004539335", "3011213605", "3003917514", "1000115322", "3007382160", "1832816", "3010713600" ], "device_name": "Glucose Oxidase, Glucose", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1345", "device_class": "2" } } ] }