{ "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": "177454", "product_res_number": "Z-0761-2020", "event_date_initiated": "2019-10-16", "event_date_created": "2019-12-31", "recall_status": "Terminated", "event_date_terminated": "2020-05-04", "res_event_number": "84166", "product_code": "MMI", "k_numbers": [ "K031739", "K051433" ], "product_description": "i-STAT cTnI cartridge", "code_info": "List Number: 06P23-25 UDI: (01)00054749001986", "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": "609-454-9000", "reason_for_recall": "i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.", "root_cause_description": "Device Design", "action": "On October 16, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail. It explains Abbott Point of Care has made the decision to transition U.S. customers using the i-STAT cTnI blue cartridge, list number 06P23-25, to the i-STAT cTnI white cartridge, list number 03P90-25, beginning in November 2019. The i-STAT cTnI blue cartridge, list number 06P23-25, will be discontinued for sale in the United States as of January 1, 2020. \n\nIt further explains to customers while the i-STAT cTnI blue cartridges can continue to be used for patient testing, APOC recommends that all users of the i-STAT System be informed of the possibility of a higher than expected number of quality check codes while using the i-STAT cTnI blue cartridge and maintain a validated alternate backup method until the i-STAT cTnI white cartridges are received.\n\nYour Abbott Point of Care representative will contact you to discuss the details and timing of this transition for your facility.\n\nIf your facility repeatedly observes the i-STAT cTnI blue cartridges from a single lot generating a higher than expected number of QCCs, please contact APOC Technical Services for support and to report the information.\n\nIf you have forwarded any i-STAT cTnI blue cartridges to another facility, please provide a copy of this letter to them.\n\nADDITIONAL INFORMATION\nIf you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 1-866-324-8114, or via email at apoc_cTnIproductinfo@abbott.com or contact your Abbott Point of Care support services representative.\n\nWe appreciate your understanding in this matter and thank you for your continued support of Abbott and Abbott products.", "product_quantity": "3,465,875", "distribution_pattern": "US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY", "openfda": { "k_number": [ "K230648", "K984105", "K172783", "K961500", "K121790", "K993353", "K973616", "K984359", "K974839", "K052503", "K024193", "K252393", "K000784", "K051925", "K190675", "K980528", "K033745", "K955868", "K955284", "K981882", "K171566", "K241165", "K983972", "K041619", "K253051", "K242870", "K020662", "K060875", "K010562", "K182225", "K053577", "K973650", "K963934", "K040733", "K984093", "K030950", "K991177", "K082699", "K102441", "K050644", "K050975", "K191595", "K031031", "K100130", "K230994", "K012820", "K021814", "K010429", "K974818", "K952478", "K974075", "K121214", "K222881", "K240984", "K014105", "K202525", "K010201", "K992127", "K991795", "K951890", "K053020", "K062838", "K041811", "K201441", "K972094", "K964862", "K020950", "K063243", "K992366", "K051752", "K974103", "K924392", "K030057", "K023505", "K041192", "K063756", "K014024", "K042227", "K162895", "K031739", "K102131", "K981098", "K171274", "K013062", "K081643", "K964372", "K010313", "K172787", "K231974", "K963513", "K033487", "K243483", "K022946", "K993309", "K070640" ], "registration_number": [ "3002637618", "3022178699", "1181121", "3002806944", "2250051", "2122870", "2432235", "1036362", "9612316", "3009448641", "2060833", "9610987", "3005643513", "2246703", "3003589956", "8031673", "8020888", "2029372", "3004205692", "1219913", "9610126", "2032682", "3002809144", "3005094123", "3005174594", "3010825766", "3006198300", "3007111389", "3005360469", "2020726", "1832216", "3005984081", "2245578", "2025099", "1319681", "3012963943", "1827821", "2032839", "3002642396", "3000308930", "3014353045", "2435505", "3005333358", "3026478116", "3029973107", "3013982035", "3003366417", "9680746", "2517506", "3026478115", "3005529799" ], "fei_number": [ "3002637618", "3022178699", "1181121", "3002806944", "3002808328", "2250051", "2122870", "3004185580", "2432235", "1036362", "3009448641", "2246703", "3005643513", "3003589956", "2967", "1000306617", "1000136573", "3004205692", "1219913", "3002809144", "3002807710", "3005094123", "3005174594", "3010825766", "3007019572", "3006198300", "3007111389", "2020726", "3005984081", "1832216", "2245578", "3002806559", "3007981058", "3012963943", "1827821", "3002642396", "3000308930", "3014353045", "3003952975", "3005333358", "1000206808", "3005670738", "3029973107", "1000119795", "3026478116", "3013982035", "3003366417", "3001452245", "2517506", "3026478115", "3005529799" ], "device_name": "Immunoassay Method, Troponin Subunit", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1215", "device_class": "2" } } ] }