{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "64351", "product_res_number": "Z-0289-2008", "event_date_initiated": "2007-08-31", "event_date_created": "2015-06-25", "recall_status": "Terminated", "event_date_terminated": "2008-03-25", "res_event_number": "44752", "product_code": "LCP", "k_numbers": [ "K051321" ], "product_description": "A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care.", "code_info": "Model Number 03022-Lot Numbers 0707812, 0707813, 0707814, and 0707815.", "firm_fei_number": "3002940409", "recalling_firm": "Metrika Inc", "address_1": "510 Oakmead Pkwy", "city": "Sunnyvale", "state": "CA", "postal_code": "94085-4022", "additional_info_contact": "408-524-2255 Ext. 290", "reason_for_recall": "Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.", "root_cause_description": "Process control", "action": "A September 14, 2007, Urgent Device Recall letter was issued to all Distribution Center Managers to return recalled product for replacement. Customer notification was made via a Dear Healthcare Professional letter dated Sept. 14, 2007, also titled Urgent Medical Device Recall.", "product_quantity": "4,286", "distribution_pattern": "Nationwide including states of AK, AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico.", "openfda": { "k_number": [ "K880698", "K830935", "K091400", "K121492", "K790583", "K053411", "K070452", "K110188", "K140829", "K071466", "K936204", "K860572", "K000885", "K071132", "K183230", "K140801", "K852111", "K810638", "K111128", "K801289", "K811567", "K935613", "K122472", "K934070", "K781851", "K822867", "K963844", "K012410", "K801561", "K852986", "K974491", "K884184", "K000887", "K921676", "K080618", "K792086", "K021897", "K040872", "K100304", "K904814", "K871679", "K875354", "K983253", "K192987", "K812242", "K041444", "K013465", "K033674", "K902457", "K042193", "K050178", "K110313", "K020235", "K864643", 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"regulation_number": "864.7470", "device_class": "2" } } ] }