{"recall":{"id":"fda-device-99389","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin REF: 11537225","firm":"Siemens Healthcare Diagnostics, Inc.","date":"2026-07-06","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic","code":"All Lots within expiry/UDI: 00630414611099","quantity":"7018 units","number":"Z-2890-2026","classification":"Class II"}],"reason":"Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.¿","nationwide":true,"states":[],"units":"7018 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=99389","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"250b1450e603e948","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=99389","record":[{"status":"Ongoing","city":"Tarrytown","state":"NY","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99389","recalling_firm":"Siemens Healthcare Diagnostics, Inc.","address_1":"511 Benedict Ave","address_2":"","postal_code":"10591-5005","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.¿","recall_number":"Z-2890-2026","product_description":"Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic","product_quantity":"7018 units","reason_for_recall":"Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.","recall_initiation_date":"20260706","center_classification_date":"20260805","report_date":"20260812","code_info":"All Lots within expiry/UDI: 00630414611099","more_code_info":""}]}}