{"recall":{"id":"fda-device-99379","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Siemens Healthcare Diagnostics, Inc. recalls Syva Emit Disopyramide Assay Enzyme Immunoassay","firm":"Siemens Healthcare Diagnostics, Inc.","date":"2026-06-26","reported":"2026-08-12","status":"Ongoing","classification":"Class III","products":[{"name":"Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL","code":"UDI-DI 00842768001406 Lot U1","quantity":"8 US; 44 OUS","number":"Z-2880-2026","classification":"Class III"}],"reason":"Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.","nationwide":true,"states":[],"units":"8 US; 44 OUS","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=99379","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5f27358470306eb1","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=99379","record":[{"status":"Ongoing","city":"Newark","state":"DE","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99379","recalling_firm":"Siemens Healthcare Diagnostics, Inc.","address_1":"500 Gbc Dr","address_2":"","postal_code":"19702-2466","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.","recall_number":"Z-2880-2026","product_description":"Syva Emit Disopyramide Assay  Enzyme Immunoassay, Lidocaine  SMN 10445370  Catalog No 6N319UL","product_quantity":"8 US; 44 OUS","reason_for_recall":"Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.","recall_initiation_date":"20260626","center_classification_date":"20260804","report_date":"20260812","code_info":"UDI-DI 00842768001406 Lot U1","more_code_info":""}]}}