{"recall":{"id":"fda-device-99214","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 Enzymatic Hemoglobin A1c (A1c_E)","firm":"Siemens Healthcare Diagnostics, Inc.","date":"2026-06-08","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.","code":"Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.","quantity":"24,077 units","number":"Z-2703-2026","classification":"Class II"}],"reason":"The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina¿Faso, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Democratic Republic Congo, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Poland, Portugal, Qatar, Republic of Korea, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Thailand, Turkey, Turkmenistan, U.A.E., Uganda, United¿Kingdom, Uruguay, Vatican City, Vietnam.","nationwide":true,"states":[],"units":"24,077 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=99214","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"94053679dd9e1f5c","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=99214","record":[{"status":"Ongoing","city":"Tarrytown","state":"NY","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99214","recalling_firm":"Siemens Healthcare Diagnostics, Inc.","address_1":"511 Benedict Ave","address_2":"N/A","postal_code":"10591-5005","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina¿Faso, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Democratic Republic Congo, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Poland, Portugal, Qatar, Republic of Korea, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Thailand, Turkey, Turkmenistan, U.A.E., Uganda, United¿Kingdom, Uruguay, Vatican City, Vietnam.","recall_number":"Z-2703-2026","product_description":"Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.","product_quantity":"24,077 units","reason_for_recall":"The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.","recall_initiation_date":"20260608","center_classification_date":"20260708","report_date":"20260715","code_info":"Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers."}]}}