{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "219276", "product_res_number": "Z-1999-2026", "event_date_initiated": "2026-04-01", "event_date_posted": "2026-04-29", "recall_status": "Open, Classified", "res_event_number": "98635", "product_code": "CHL", "k_numbers": [ "K940918" ], "product_description": "i-STAT EG7+ cartridge;\nList Number: 03P76-25;", "code_info": "List Number: 03P76-25;\nUDI-DI: 00054749000043;\nLot numbers: N25206, N25207, N25209, N25213, N25218, N25219, N25233;", "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": "Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.", "root_cause_description": "Process change control", "action": "On April 1, 2026, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. This Urgent Medical Device Corrective is to customers in the U.S. with the following recommended actions:\n\" Discontinue use of the affected i-STAT EG7+, EG6+, and G3+ cartridge lots for reporting PCO and pH results.\n\" Use an alternate cartridge type, alternate lot, or testing method.\n\" Complete and return the Business Reply Card included with this notification to confirm receipt and understanding.\nIf you have forwarded any of the specified i-STAT EG7+, EG6+ or G3+ cartridges to another facility, we request that you please provide a copy of this letter to them.", "product_quantity": "369650 units (150875 US, 218775 OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.", "openfda": { "k_number": [ "K061974", "K974526", "K122729", "K944089", "K936081", "K831015", "K820744", "K953935", "K002738", "K022746", "K832981", "K842519", "K936203", "K994346", "K151978", "K781968", "K123748", "K813517", "K080370", "K223857", "K854608", "K991417", "K942616", "K141907", "K002290", "K914560", "K760748", "K160153", "K963800", "K890827", "K240998", "K955793", "K110416", "K831023", "K881188", "K844781", "K940918", "K961161", "K840843", "K771253", "K945240", "K810308", "K800224", "K133407", "K151856", "K904188", "K131126", "K771147", "K934907", "K151982", "K961657", "K850360", "K200492", "K831024", "K780716", "K200107", "K974396", "K800271", "K833534", "K943882", "K993789", "K792230", "K221900", "K831017", "K093280", "K954711", "K031560", "K853405", "K970710", "K853840", "K882941", "K831025", "K831010", "K833536", "K142898", "K023567", "K946206", "K935830", "K192240", "K992859", "K884267", "K252207", "K831020", "K821483", "K831021", "K914166", "K982928", "K014295", "K963964", "K050423", "K973367", "K904513", "K834601", "K810724", "K823570", "K932642", "K110648", "K961335", "K954612", "K820597", "K852790", "K980991", "K984384", "K000103", "K120197", "K812623", "K891578", "K865036", "K131988", "K943643", "K864445", "K913927", "K954482", "K173797", "K812090", "K230285", "K200986", "K211559", "K831012", "K831016", "K130144", "K823750", "K193246", "K063376", "K244014", "K935069", "K831379", "K142220", "K915087", "K902267", "K770736", "K980523", "K844295", "K043218", "K122642", "K871397", "K980130", "K012478", "K831018", "K935655", "K943570", "K122539", "K992834", "K002613", "K131703", "K800757", "K051804", "K760229", "K922631", "K882209", "K860057", "K772307", "K903965", "K223608", "K884143", "K863880", "K895181", "K962021", "K831019", "K832779", "K982277", "K840300", "K111188", "K111897", "K812552", "K020297", "K924758", "K935121", "K012058", "K100777", "K160412", "K021713", "K990092", "K760969", "K041874", "K203790", "K895317", "K013729", "K831013", "K021515", "K873577", "K924497", "K922922", "K173403", "K841609", "K840468", "K852676", "K771822" ], "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": [ "1219913", "3005643513", "3015997711", "2245578", "3007662974", "3002637618", "3012104670", "3002807968", "1220649", "2432235", "1220972", "1000455123", "1717966", "9610633", "8030478", "3014506106", "1217183", "1036362", "3012817228", "2050012", "3023162659", "3013513377", "3004959793", "3004102403", "1222035", "9610126", "3006198300", "2431530", "1219029", "3037000637", "3003795116", "3003971136", "1181121", "3007490412" ], "fei_number": [ "3002806559", "1219913", "3005643513", "3015997711", "2245578", "3007662974", "3002637618", "3012104670", "3002807968", "1220649", "2432235", "1220972", "1000455123", "1717966", "3002806693", "3014506106", "3001576181", "1217183", "1036362", "3012817228", "2050012", "3023162659", "3013513377", "3004959793", "3004102403", "1222035", "3006198300", "2431530", "1219029", "3037000637", "3003795116", "3003971136", "1181121", "3007490412" ] } } ] }