{"recall":{"id":"fda-device-99724","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"TECHNO-PATH MANUFACTURING LTD. recalls 3 products","firm":"TECHNO-PATH MANUFACTURING LTD.","date":"2026-08-14","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Techno-Path Multichem AE Unassayed Level 1 REF:AE621X","code":"UDI: (01)05391523442800/Lot # 65705261","quantity":"832 units","number":"Z-0205-2027","classification":"Class II"},{"name":"Techno-Path Multichem AE Unassayed Level 2 REF: AE622X","code":"UDI:(01)05391523442817/Lot # 65705262","quantity":"123 units","number":"Z-0206-2027","classification":"Class II"},{"name":"Techno-Path Multichem AE Unassayed Level 3, REF:AE623X","code":"UDI:(01)05391523442824/-Lot # 65705263","quantity":"832 units","number":"Z-0207-2027","classification":"Class II"}],"reason":"A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of Massachusetts.","nationwide":true,"states":[],"units":"832 units; 123 units; 832 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=99724","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"39fb0fdd9c988cf9","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=99724","record":[{"status":"Ongoing","city":"Ballina Tipperary","state":"","country":"Ireland","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99724","recalling_firm":"TECHNO-PATH MANUFACTURING LTD.","address_1":"Fort Henry Business Park","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of Massachusetts.","recall_number":"Z-0205-2027","product_description":"Techno-Path  Multichem AE Unassayed Level 1  REF:AE621X","product_quantity":"832 units","reason_for_recall":"A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only.     The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.","recall_initiation_date":"20260814","center_classification_date":"20261022","report_date":"20261028","code_info":"UDI: (01)05391523442800/Lot # 65705261","more_code_info":""},{"status":"Ongoing","city":"Ballina Tipperary","state":"","country":"Ireland","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99724","recalling_firm":"TECHNO-PATH MANUFACTURING LTD.","address_1":"Fort Henry Business Park","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of Massachusetts.","recall_number":"Z-0206-2027","product_description":"Techno-Path Multichem AE Unassayed Level 2  REF: AE622X","product_quantity":"123 units","reason_for_recall":"A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only.     The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.","recall_initiation_date":"20260814","center_classification_date":"20261022","report_date":"20261028","code_info":"UDI:(01)05391523442817/Lot # 65705262","more_code_info":""},{"status":"Ongoing","city":"Ballina Tipperary","state":"","country":"Ireland","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99724","recalling_firm":"TECHNO-PATH MANUFACTURING LTD.","address_1":"Fort Henry Business Park","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of Massachusetts.","recall_number":"Z-0207-2027","product_description":"Techno-Path Multichem AE Unassayed Level 3, REF:AE623X","product_quantity":"832 units","reason_for_recall":"A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only.     The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.","recall_initiation_date":"20260814","center_classification_date":"20261022","report_date":"20261028","code_info":"UDI:(01)05391523442824/-Lot # 65705263","more_code_info":""}]}}