{"recall":{"id":"fda-device-99266","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Bioporto Diagnostics A/S recalls ProNephro AKI (NGAL) Reagent Kit (100 tests)","firm":"Bioporto Diagnostics A/S","date":"2026-05-18","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.","code":"Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.","quantity":"400 units","number":"Z-2937-2026","classification":"Class II"}],"reason":"The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - The affected product distribution included the United States and the countries of European Union, Chile, and Hong Kong. No affected product was distributed to Canada; however, Health Canada was notified because the product is registered in Canada.","nationwide":false,"states":[],"units":"400 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99266","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d0dec873201a18ce","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99266","record":[{"status":"Ongoing","city":"Hellerup","state":"","country":"Denmark","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99266","recalling_firm":"Bioporto Diagnostics A/S","address_1":"Tuborg Havnevej 15, St","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide - The affected product distribution included the United States and the countries of European Union, Chile, and Hong Kong. No affected product was distributed to Canada; however, Health Canada was notified because the product is registered in Canada.","recall_number":"Z-2937-2026","product_description":"ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.","product_quantity":"400 units","reason_for_recall":"The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in  intended users.","recall_initiation_date":"20260518","center_classification_date":"20260812","report_date":"20260819","code_info":"Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.","more_code_info":""}]}}