{ "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": "105712", "product_res_number": "Z-0824-2012", "event_date_initiated": "2011-05-30", "event_date_posted": "2012-01-20", "recall_status": "Terminated", "event_date_terminated": "2012-03-02", "res_event_number": "60539", "product_code": "CGA", "k_numbers": [ "K020935" ], "product_description": "HemoCue Glucose 201 Microcuvettes, \n\nArticle Number:110705*,110706,110715**,110716**,110717**,110718**,\n110719**\n\n\n\" No affected lots of this article have been delivered to customers. Still\nin stock at distributor HemoCue Inc.\n\"\" Article not available in US\n\n\nQuantitative determination of glucose in whole blood, using a specially designed analyzer, the HemoCue Glucose 201 Analyzer. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use only and are only to be used with the HemoCue Glucose 201 Analyzer. For professional use only.", "code_info": "Lot/batch Number:   US: 1011383*, 1102471 *,1102474*,1102487*,1103200*, 1103201**,1103236*,1103213*,1103216*,1103224*, 1103225*,1103226*,1103238*,1103243**,1103246*, 1103250*,1103496*,1103498*,1104272**,1104273**, 1104288**,1104289**,1104548**,1104549**,1104550**, 1104555**,1104556**,1104558**,1104559**,1103212*, 1103240*,1104557**  * lots have been shipped to customers ** lots are in stock at distributor HemoCue Inc.  Not in US: 1104282, 1105306, 1104530, 1103242, 1103241, 1103244,1103247,1104255,1104258,1103248,1103234, 1104260,1104267,1104274,1104270,1102467,1104277, 1104531,1104532,1104533,1104534,1104535,1103227, 1103228,1103232,1103230,1103233,1104254,1104256, 1103249,1104254,1103245,1104263,1104274,1104286, 1104275,1104283.  The lots that are not for the US market are not affected by the labeling infonnation regarding lithium heparin.", "firm_fei_number": "3005104838", "recalling_firm": "Hemo Cue, Inc.", "address_1": "11331 Valley View St", "city": "Cypress", "state": "CA", "postal_code": "90630-5366", "reason_for_recall": "A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections.", "root_cause_description": "Packaging process control", "action": "HemoCue sent a Medical Device Correction Notification letter dated June 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\n Customers were instructed to passed on the notice to all that need to be aware with their organization or to any organization where the affected lot numbers have been distributed. Customers were instructed to sign the Correction Notification Verification form below and return to HemoCue Inc. Customers received the revised package insert with the notification letter. \n\nCustomers with any questions regarding the Correction Notification could please call (562) 668-5665.", "product_quantity": "13,620 packages", "distribution_pattern": "Worldwide Distribution--USA (nationwide) and the countries of Czech Republic, Denmark, Slovenia, Norway, Sweden, Switzerland, United Kingdom, Finland, Germany, Netherlands, Poland, Romania, and Tanzania.", "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", 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