{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "215607", "product_res_number": "Z-2583-2025", "event_date_initiated": "2025-08-21", "event_date_posted": "2025-09-17", "recall_status": "Open, Classified", "res_event_number": "97443", "product_code": "CHL", "product_description": "i-STAT CG8+ cartridge. List Number: 03P88-25. \n\n510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300", "code_info": "List Number: 03P88-25. All lot numbers.", "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": "Ellen Wichman\n224-667-8522", "reason_for_recall": "Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.", "root_cause_description": "No Marketing Application", "action": "Abbott notified consignees via email and letter on about 08/21/2025. Consignees were instructed to download, review and implement the updated i-STAT CG8+, EG7+ and EG6+ cartridge Instructions for Use (IFU), discontinue use of i-STAT CG8+, EG7+ and EG6+ cartridges for testing of capillary whole blood samples for potassium and ionized calcium, and use venous or arterial whole blood or an alternate method for testing capillary potassium and ionized calcium. Update the pH and PO2 reportable ranges on the i-STAT 1 analyzers running i-STAT CG8+, EG7+ or EG6+ cartridges. As this feature is not customizable through the i STAT 1 handheld keypad, please see the i STAT DE Quick Reference Guide - Customizing Reportable Ranges (ART 770547-00 Revision A) for more information. To use the Custom Reportable Range feature, you must have the i-STAT 1 handheld and i STAT DE version 2.3 or higher. Changes to the reportable range may require a change to the Laboratory Information System (LIS) interface. Additionally, consignees were requested to confirm receipt and understanding of this communication by responding to the business reply card included with the letter. If consignees have forwarded any i-STAT CG8+, EG7+ or EG6+ cartridges to another facility, they were requested to notify them.", "product_quantity": "8,962,450 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K890827", "K142220", "K012478", "K932642", "K844295", "K884267", "K133407", "K151982", "K961161", "K935121", "K131988", "K012058", "K936081", "K100777", "K050423", "K831010", "K111897", "K192240", "K945240", "K924758", "K935655", "K230285", "K760748", "K772307", "K943570", "K863880", "K131126", "K200986", "K110648", "K853405", "K831019", "K813517", "K991417", "K973367", "K122539", "K244014", "K970710", "K834601", "K013729", "K043218", "K120197", "K984384", "K821483", "K852676", "K935069", "K780716", "K781968", "K771147", "K002613", "K812552", "K954612", "K831023", "K980991", "K031560", "K820597", "K904188", "K831025", "K063376", "K014295", "K223608", "K974526", "K853840", "K902267", "K936203", "K860057", "K800271", "K840843", "K992859", "K142898", "K854608", "K221900", "K962021", "K160412", "K760229", "K770736", "K831016", "K963964", "K955793", "K982928", "K842519", "K110416", "K881188", "K173797", "K831012", "K810308", "K041874", "K980523", "K831018", "K023567", "K080370", "K831024", "K922922", "K151856", "K111188", "K961335", "K934907", "K915087", "K940918", "K130144", "K982277", "K051804", "K935830", "K961657", "K954482", "K131703", "K865036", "K240998", "K922631", "K953935", "K211559", "K792230", "K160153", "K800757", "K812090", "K882209", "K061974", "K832981", "K122642", "K963800", "K141907", "K022746", "K990092", "K943882", "K946206", "K913927", "K844781", "K924497", "K895317", "K831017", "K833536", "K942616", "K833534", "K820744", "K823750", "K823570", "K002290", "K193246", "K223857", "K852790", "K832779", "K994346", "K122729", "K021515", "K831013", "K895181", "K864445", "K831379", "K993789", "K200107", "K000103", "K840468", "K903965", "K873577", "K850360", "K203790", "K884143", "K093280", "K871397", "K944089", "K891578", "K151978", "K974396", "K882941", "K002738", "K123748", "K831015", "K760969", "K831021", "K904513", "K914166", "K812623", "K980130", "K200492", "K914560", "K841609", "K992834", "K800224", "K954711", "K831020", "K020297", "K252207", "K771822", "K021713", "K943643", "K173403", "K840300", "K810724", "K771253" ], "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1120", "device_class": "2", "registration_number": [ "3014506106", "3013513377", "3012817228", "1000455123", "3002637618", "2050012", "9610633", "1217183", "3007490412", "3023162659", "2431530", "3002807968", "3004102403", "8030478", "3012104670", "3037000637", "1717966", "3015997711", "1219913", "3003795116", "3003971136", "1222035", "9610126", "2245578", "1181121", "1036362", "3007662974", "3006198300", "1220972", "1219029", "1220649", "2432235", "3005643513", "3004959793" ], "fei_number": [ "3014506106", "3013513377", "3012817228", "1000455123", "3002637618", "2050012", "1217183", "3007490412", "3023162659", "2431530", "3002807968", "3004102403", "3012104670", "3037000637", "1717966", "3015997711", "1219913", "3003795116", "3003971136", "1222035", "2245578", "1181121", "1036362", "3002806559", "3007662974", "3006198300", "3001576181", "1220972", "1219029", "1220649", "2432235", "3002806693", "3005643513", "3004959793" ] } } ] }