{"recall":{"id":"fda-device-99446","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Siemens Healthcare Diagnostics, Inc. recalls 2 products","firm":"Siemens Healthcare Diagnostics, Inc.","date":"2026-07-13","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL","code":"Lot U1/UDI: 00842768001048","quantity":"20 units","number":"Z-2975-2026","classification":"Class II"},{"name":"Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL","code":"Lots: 2597, 2627, 2709/UDI: 00842768023293","quantity":"55 units","number":"Z-2976-2026","classification":"Class II"}],"reason":"Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the state of CA and the country of Italy.","nationwide":true,"states":[],"units":"20 units; 55 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=99446","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"8add45e69ed6d8af","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=99446","record":[{"status":"Ongoing","city":"East Walpole","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99446","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 state of CA and the country of Italy.","recall_number":"Z-2975-2026","product_description":"Syva EMIT 2000 Quinidine Assay  REF: 4Q019UL  Contents: 1x28 mL, 1x14mL","product_quantity":"20 units","reason_for_recall":"Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.","recall_initiation_date":"20260713","center_classification_date":"20260817","report_date":"20260826","code_info":"Lot U1/UDI: 00842768001048","more_code_info":""},{"status":"Ongoing","city":"East Walpole","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99446","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 state of CA and the country of Italy.","recall_number":"Z-2976-2026","product_description":"Beckman Coulter, Emit 2000 Quinidine Assay  REF: OSR4Q229  Contents: R1: 2 x 23 mL;R2 2x13 mL","product_quantity":"55 units","reason_for_recall":"Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.","recall_initiation_date":"20260713","center_classification_date":"20260817","report_date":"20260826","code_info":"Lots: 2597, 2627, 2709/UDI: 00842768023293","more_code_info":""}]}}