{ "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": 1 } }, "results": [ { "cfres_id": "215606", "product_res_number": "Z-2582-2025", "event_date_initiated": "2025-08-21", "event_date_posted": "2025-09-17", "recall_status": "Open, Classified", "res_event_number": "97442", "product_code": "CHL", "k_numbers": [ "K244014", "K940918", "K982071" ], "product_description": "i-STAT CG4+ cartridge (white). List Number: 03P85-25.", "code_info": "List Number: 03P85-25. 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 CG4+ cartridge to reflect updated sample type for lactate 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 CG4+ cartridge Instructions for Use (IFU), discontinue use of the i-STAT CG4+ cartridges for testing of capillary whole blood samples for lactate and instead use venous or arterial whole blood or an alternate method for testing capillary whole blood for lactate, and update the pH and PO2 reportable ranges on the i-STAT 1 analyzers running i-STAT CG4+ cartridges. 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). 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 CG4+ cartridges to another facility, they were requested to notify them.", "product_quantity": "9,067,050 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" ] } } ] }