{ "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": "123293", "product_res_number": "Z-0451-2014", "event_date_initiated": "2013-10-28", "event_date_posted": "2013-12-04", "recall_status": "Terminated", "event_date_terminated": "2014-05-29", "res_event_number": "66757", "product_code": "GJS", "k_numbers": [ "K020355" ], "product_description": "Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540\r\n\r\nThe i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.", "code_info": "K020355  List number 04J50-01, 04J50-02; 03P89-24  Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A", "firm_fei_number": "2245578", "recalling_firm": "Abbott Point Of Care Inc.", "address_1": "400 College Rd E", "city": "Princeton", "state": "NJ", "postal_code": "08540-6607", "additional_info_contact": "Abbott Point of Care Technical Support\n800-366-8020", "reason_for_recall": "Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.", "root_cause_description": "Nonconforming Material/Component", "action": "Abbott Point of Care Inc. (APOC) issued an Urgent Recall Notice on October 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from PT/INR lots in this letter. All unused cartridges would be credited and are to be returned as instructed on the enclosed Business Reply Card. If customers provided cartridges from the lot number listed above to another institution they were instructed to provide a copy of this letter to them.\r\nCustomers with questions were instructerd to contact Abbott Point of Care Technical at 1-800-366-8020, Option 1.\r\nFor questions regarding this recall call 800-366-8020.", "product_quantity": "794,928 units US; 119,472 units OUS", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,", "openfda": { "k_number": [ "K952608", "K092987", "K884855", "K001699", "K933252", "K180780", "K243543", "K183255", "K231711", "K940082", "K904454", "K874592", "K810350", "K891169", "K013155", "K020831", "K905857", "K972866", "K935748", "K920767", "K940432", "K864272", "K961938", "K093460", "K991065", "K942884", "K922040", "K974343", "K864273", "K905807", "K151964", "K901325", "K020679", "K851125", "K170960", "K840802", "K012768", "K880566", "K864274", "K043184", "K052124", "K896625", "K212779", "K030845", "K213426", "K904325", "K811784", "K974566", "K791023", "K994100", "K022922", "K092940", "K882456", "K870596", "K954625", "K882214", "K893378", "K020355", "K780203", "K903019", "K062925", "K021190", "K955843", "K930212", "K994006", "K945078", "K902096", "K071041", "K832427", "K931118", "K915746", "K093243", "K864283", "K072727", "K020840", "K913250", "K922565", "K040296", "K070005", "K961835", "K885107", "K792031", "K843535", "K911995", "K962571", "K852484", "K951820", "K902468", "K931117", "K913249", "K211485", "K122584", "K860721", "K991286", "K875062", "K180693", "K972796", "K925492", "K230802", "K981479", "K925604", "K872537", "K921326", "K883441", "K992492", "K132722", "K010599", "K872844", "K220282", "K940310", "K060978", "K892050", "K791022", "K180684", "K110212", "K253188", "K891370", "K830331", "K072920", "K912102", "K060931", "K935702", "K003870", "K201185", "K864392", "K021923", "K251564" ], "device_name": "Test, Time, Prothrombin", "medical_specialty_description": "Hematology", "regulation_number": "864.7750", "device_class": "2", "registration_number": [ "2432235", "1219029", "3013188547", "3013298431", "3013660430", "1835316", "9610806", "3006198300", "3005643513", "2431530", "3037000637", "3011689956", "9610126", "1618982", "2085064", "1181121", "2245451", "3008386529", "2245578", "3010285483", "1217183", "3005146313", "3003691680", "3025915415", "9710666", "3002721930", "3030186688", "3007507465", "3012302888", "1832816", "3015499222", "3033967997" ], "fei_number": [ "2432235", "1219029", "3002806559", "3013188547", "3013298431", "3013660430", "3006198300", "3000210416", "3005643513", "2431530", "3037000637", "3011689956", "1618982", "1000135102", "1181121", "2245451", "3008386529", "2245578", "3010285483", "1217183", "3005146313", "3003565434", "3003691680", "3025915415", "3001644026", "2250033", "3030186688", "3007507465", "3012302888", "1832816", "3015499222", "3033967997" ] } } ] }