{ "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": "49903", "product_res_number": "Z-0376-2007", "event_date_initiated": "2006-11-17", "event_date_posted": "2007-01-25", "recall_status": "Terminated", "event_date_terminated": "2007-11-28", "res_event_number": "37097", "product_code": "JIT", "k_numbers": [ "K041444" ], "product_description": "Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.", "code_info": "Diluent lot number AA61508, Catalog number for recalled diluent: 220-0119, expiration date 11/30/07 Catalog number for whole kit: 220-0201. Reorder pack lot numbers 2006 1537, 2006 1555, 2006 1561, 2006 1557, 2006 1597, 2006 1600, 2006 1745, 2006 2007. Expiration dates on hte above catalog numbers: 04/30/2007, except for 2006 1557, which is 2/28/07. The diluent is packaged with either HbA1c Calibrators (cat number 220-0128, lot number S61409, exp. date 5/31/2007), or HbA2/F/A1c calibrators (cat number 220-218, exp date 5/31/07. Calibrator diluent that comes with the kit has an expiration date of AA61408", "firm_fei_number": "2915274", "recalling_firm": "Bio-Rad Laboratories Inc", "address_1": "4000 Alfred Nobel Dr", "city": "Hercules", "state": "CA", "postal_code": "94547-1803", "reason_for_recall": "The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.", "root_cause_description": "Other", "action": "The firm has issued phone calls and faxes to its US consignees starting 11/17/2006 and International notices began on 11/20/2006 explaining the reason for the recall and requesting the product be disposed.", "product_quantity": "900 kits, 43 sets distributed.", "distribution_pattern": "Worldwide, including USA, India, Canada, France, Sweden, the UK, Hong Kong, Singapore, Germany, Brazil, Italy, China, Costa Rica and Panama.", "openfda": { "k_number": [ "K963493", "K170160", "K771802", "K010334", 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