{"recall":{"id":"fda-device-99381","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 tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No","firm":"Siemens Healthcare Diagnostics, Inc.","date":"2026-06-26","reported":"2026-08-12","status":"Ongoing","classification":"Class III","products":[{"name":"Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL","code":"UDI-DI 00842768014321 Lot U2","quantity":"494 US; 114 OUS","number":"Z-2881-2026","classification":"Class III"}],"reason":"out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. 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 CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.","nationwide":true,"states":[],"units":"494 US; 114 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=99381","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"9fffb363276f7305","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=99381","record":[{"status":"Ongoing","city":"East Walpole","state":"MA","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99381","recalling_firm":"Siemens Healthcare Diagnostics, Inc.","address_1":"333 Coney St","address_2":"","postal_code":"02032-1516","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.","recall_number":"Z-2881-2026","product_description":"Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls  SMN 10445390  Catalog No. 7C219UL","product_quantity":"494 US; 114 OUS","reason_for_recall":"out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. 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 00842768014321 Lot U2","more_code_info":""}]}}