{ "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": "121322", "product_res_number": "Z-0020-2014", "event_date_initiated": "2013-08-12", "event_date_posted": "2013-10-17", "recall_status": "Terminated", "event_date_terminated": "2015-04-06", "res_event_number": "66047", "product_code": "CEO", "k_numbers": [ "K981759" ], "product_description": "Clinical Chemistry Phosphorus Reagent \r\n\r\nThe Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.", "code_info": "For List Number: 7D71-22, Lot Numbers 64736UN12 (Exp Date on Label is 14 JAN 2014), 03991UN13 (Exp Date on Label is 01 APR 2014), and 51611UN13 (Exp Date on Label is 13 JUL 2014). For List Number: 7D71-31, Lot Numbers 74805UN12 (Exp Date on Label is 14 JAN 2014) and 03992UN13 (Exp Date on Label is 01 APR 2014).", "firm_fei_number": "1628664", "recalling_firm": "Abbott Laboratories, Inc", "address_1": "1921 Hurd Dr", "city": "Irving", "state": "TX", "postal_code": "75038-4313", "additional_info_contact": "972-518-6001", "reason_for_recall": "Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.", "root_cause_description": "Error in labeling", "action": "The firm, Abbott Laboratories, sent a \"PRODUCT CORRECTION\" letter dated August 12, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to update existing inventory and manually track the implanted lots with the corrected expiration dates listed in the letter; retain a copy of letter and if you have forwarded any of the lots listed to another laboratory, provide a copy of the letter to them.\r\n\r\nIf you or any of your healthcare providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (422-2688). Customers outside the U.S., please contact your local area customer service.", "product_quantity": "7213", "distribution_pattern": "Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Austria, Australia, Azerbaijan, Bangladesh, Bahamas, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Burkina, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania ,Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, United Arab Emirates, United Kingdom, Uruguay and Vietnam.", "openfda": { "k_number": [ "K955937", "K852003", "K041643", "K770820", "K760030", "K870776", "K884735", "K931835", "K900977", "K901137", "K925057", "K971363", "K881171", "K844182", "K761238", "K100263", "K072141", "K841061", "K932729", "K802159", "K981759", "K771477", "K771848", "K761239", "K870368", "K871321", "K833002", "K855154", "K843330", "K883962", "K843177", "K770456", "K895999", "K863088", "K850380", "K850986", "K854188", "K771835", "K860628", "K874153", "K981610", "K800690", "K942960", "K912569", "K844316", "K935178", "K924470", "K974605", "K915708", "K974858", "K003012", "K823580", "K901964", "K822470", "K863718", "K890773", "K850934", "K760634", "K791708", "K874577", "K781806", "K923764", "K901807", "K790021", "K813400", "K861661", "K003912", "K874472", "K873454", "K840215", "K931361", "K885041", "K852103", "K760990", "K944768", "K823691", "K874038", "K880676", "K843030", "K863264", "K863072", "K862834", "K821874", "K022312", "K772156", "K861968", "K923564", "K945322", "K781000", "K811749", "K800297", "K903696", "K891218", "K013095", "K981118", "K912809", "K910296", "K030015", "K981769", "K900215", "K792401", "K991867", "K983503", "K945368", "K841181" ], "registration_number": [ "2432235", "1319809", "1220972", "2050012", "3006716639", "3013660430", "1827821", "3002809144", "3006198300", "1616487", "3011989923", "2939693", "9610126", "3007662974", "2085064", "1181121", "9680746", "3003741796", "2517506", "1181055", "3016438761", "2247288", "1832216", "3021841051", "3005094123", "3000148879", "3003593973", "3005333358", "1319681", "2050010", "3014325803", "2030861", "3004493545", "8020316", "9610529", "8040374", "3010825766", "3003795116" ], "fei_number": [ "2432235", "3002806559", "1220972", "1000206808", "3002806809", "2050012", "3006716639", "3013660430", "1827821", "3002809144", "3006198300", "3000215862", "1616487", "3011989923", "2939693", "3007662974", "3002806560", "1000135102", "1181121", "5864", "3003741796", "1000136573", "2517506", "1181055", "3016438761", "1832216", "3021841051", "1000305840", "3005094123", "3000148879", "3003593973", "3005333358", "2050010", "1000122044", "3014325803", "3004493545", "3010825766", "3003795116" ], "device_name": "Phosphomolybdate (Colorimetric), Inorganic Phosphorus", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1580", "device_class": "1" } } ] }