{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "94466", "product_res_number": "Z-0109-2011", "event_date_initiated": "2010-09-07", "event_date_posted": "2010-10-21", "recall_status": "Terminated", "event_date_terminated": "2011-05-17", "res_event_number": "56762", "product_code": "LCP", "k_numbers": [ "K041635" ], "product_description": "in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA.\n\nThe in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro quantitative determination of A1c (HbA1C) in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall glycemic control.", "code_info": "Product code LCP,expiration dates between 2011-07-12 and 2011-07-26. Kit lot numbers (I):072T97, 072T98, 072T100, (II): 074P75, 074P73, Device lot numbers 131Q203 38864, 131Q204 39008, 131Q206 39088", "firm_fei_number": "2915274", "recalling_firm": "Bio-Rad Laboratories Inc", "address_1": "4000 Alfred Nobel Dr", "city": "Hercules", "state": "CA", "postal_code": "94547-1803", "additional_info_contact": "510-724-7000", "reason_for_recall": "Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results.", "root_cause_description": "Component design/selection", "action": "BIO-RAD Laboratories Deeside sent an \"URGENT: MEDICAL DEVICE CORRECTION\" letter dated September 7, 2010, via registered mail to all subsidiaries/customers. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to stop using and discard the test cartridges from the listed lots; complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax +44 1244 833401; record the number of affected kits of product, confirm that they have discarded the cartridges and record the method of disposal.\n\nIf you have any questions, contact +44 1244 288888.", "product_quantity": "4056", "distribution_pattern": "Worldwide distribution: USA and countries including: Australia, New Zealand, Taiwan, France, the UK, Singapore, Germany, Italy, Thailand, China, Korea, Sweden, Sri Lanka, Maldives, Canada and the Philippines.", "openfda": { "k_number": [ "K041635", "K896582", "K993131", "K801422", "K851636", "K033674", "K893224", "K896334", "K790046", "K792086", "K231465", "K160762", "K072686", "K791428", "K142789", "K896335", "K102914", "K882051", "K042193", "K810714", "K942009", "K810638", "K991483", "K912748", "K080618", "K893453", "K140829", "K120497", 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"3003460426", "3010825766", "3002637618", "3006421415", "2432235", "1181121", "3007662974", "3017548799", "1000125596", "3006198300", "3005529799", "1832216", "1000122044" ], "device_name": "Assay, Glycosylated Hemoglobin", "medical_specialty_description": "Hematology", "regulation_number": "864.7470", "device_class": "2" } } ] }