{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "142510", "product_res_number": "Z-0649-2016", "event_date_initiated": "2014-12-08", "event_date_created": "2016-01-13", "recall_status": "Terminated", "event_date_terminated": "2016-01-13", "res_event_number": "72925", "product_code": "JIL", "k_numbers": [ "K060280" ], "product_description": "iChem 10 SG Urine Chemistry Strips, PN 800-7005.\n\nIntended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.", "code_info": "510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "reason_for_recall": "Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.", "root_cause_description": "Nonconforming Material/Component", "action": "An \"Important Product Notice,\" dated 12/8/14 was sent to customers to inform them of the recall by Iris International. The recall letter informs customers that The identified lots of iChem 10 SG Urine Chemistry Strips may have leukocyte pads that are more sensitive at the first reporting range of 1+, corresponding to 25 white blood cells (WBCs) /microliter. The letter provides the impact of the recall and the actions to taken by the customers. Customers are instructed to discard any remaining strips from the affected lots and use another lot number. Customers can either contact their local Customer Service Support or complete and return the Replacement Order form, if replacement product is needed. The enclosed response form should be completed and returned within 10 days. Customers with questions are instructed to refer to http://www.beckmancoulter.com; (800) 854-3633 in US and Canada. Customers outside the US and Canada are instructed to contact their local support representative.", "product_quantity": "16,206 vials total (7,827 vials in US)", "distribution_pattern": "Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates.", "openfda": { "k_number": [ "K932364", "K831498", "K012397", "K931897", "K042641", "K023885", "K843759", "K061742", "K181024", "K831600", "K761310", "K834385", "K811817", "K063390", "K841714", "K932367", "K834387", "K932366", "K141289", "K942648", "K120124", "K843760", "K051034", "K171083", "K940043", "K173327", "K171521", "K061846", "K991927", "K010973", "K843755", "K160062", "K895282", "K855239", "K864544", "K932368", "K020175", "K932369", "K861733", "K932363", "K940469", "K770271", "K193514", "K896454", "K843757", "K841713", "K032437", "K973142", "K771755", "K834386", "K131600", "K952307", "K052525", "K953661", "K954968", "K101673", "K932365", "K946116", "K861255", "K870500", "K843754", "K970250", "K811818", "K820594", "K091216", "K843758", "K160372", "K843753", "K183432", "K843756", "K061812", "K060280", "K063276", "K840829", "K180356", "K050801", "K022386", "K961375", "K033851", "K811816", "K952971" ], "registration_number": [ "3002637618", "", "1061932", "2244821", "1181121", "2122870", "3030446844", "1417592", "9615507", "1036362", "2432235", "3009448641", "9610633", "4580", "3010324880", "1832816", "1000414342", "2029372", "2531491", "2030633", "3003917514", "9610126", "3021186226", "3011121740", "8040374", "3006198300", "3004192065", "3008058135", "3005360469", "1649661", "1832216", "3042471840", "3007301207", "3004043187", "3009238284", "3010891909", "9611444", "3003795116", "3012494290", "3006621318", "1810909", "3012118659", "3005841640", "1616487", "3011689956", "3003422726", "2250030", "3038419886", "9680746", "3008517993", "3003741796", "3012421607", "9710094" ], "fei_number": [ "3002637618", "", "2244821", "1181121", "2122870", "3030446844", "1417592", "3000210620", "3002807423", "3003347234", "3009448641", "1036362", "2432235", "4580", "3010324880", "3002806693", "1000306617", "1832816", "3002829675", "1000414342", "3000203293", "3003917514", "3001451797", "3010700165", "3021186226", "5864", "3006198300", "3004192065", "3008058135", "1832216", "3042471840", "3007301207", "3004043187", "3002806559", "3009238284", "3010891909", "3003795116", "3012494290", "3006621318", "1810909", "3012118659", "3005841640", "1616487", "3011689956", "3003422726", "3003516723", "1000206808", "3005670738", "2250030", "3038419886", "3008517993", "3003741796", "3012421607" ], "device_name": "Method, Enzymatic, Glucose (Urinary, Non-Quantitative)", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1340", "device_class": "2" } } ] }