{"recall":{"id":"fda-device-99588","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96","firm":"Beckman Coulter Mishima K.K.","date":"2026-08-03","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.","code":"Products containing affected software: Item Numbers / UDI-DI codes: Item Number: B96692 UDI-DI code: 14987666542965 Item Number: B96693 UDI-DI code: 14987666542972 Item Number: B12183 UDI-DI code: 14987666540671 Item Number: N3151400 UDI-DI code: Due to the age of the device and the fact that it has exceeded its storage period, the UDI number is not available.)","quantity":"492 units","number":"Z-3332-2026","classification":"Class II"}],"reason":"Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, MN, MO, NC, NM, NY, OK, PA, SD, TX, and WI. The countries of Algeria, Australia, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czechia, Egypt, France, Germany, Guatemala, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, Malaysia, Morocco, Myanmar, Nepal, Nigeria, Pakistan, Poland, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, South Africa, Taiwan, Province of China, Turkey, United Arab Emirates, and Viet Nam.","nationwide":true,"states":[],"units":"492 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=99588","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"76ac7db0a888ae1c","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=99588","record":[{"status":"Ongoing","city":"Sunto-Gun","state":"","country":"Japan","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99588","recalling_firm":"Beckman Coulter Mishima K.K.","address_1":"454-32","address_2":"Higashino; Nagaizumi-Cho","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, MN, MO, NC, NM, NY, OK, PA, SD, TX, and WI. The countries of Algeria, Australia, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czechia, Egypt, France, Germany, Guatemala, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, Malaysia, Morocco, Myanmar, Nepal, Nigeria, Pakistan, Poland, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, South Africa, Taiwan, Province of China, Turkey, United Arab Emirates, and Viet Nam.","recall_number":"Z-3332-2026","product_description":"Systems/units containing affected software/SQL  BECKMAN COULTER CHEMISTRY ANALYZER AU480  REF / UDI-DI code:  B96692 / 14987666542965  B96693 / 14987666542972  B12183 / 14987666540671    The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.","product_quantity":"492 units","reason_for_recall":"Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message  System Stopped By Fatal Error: DBConnectionError AlarmDB  when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started.  This causes a delay in obtaining patient results.","recall_initiation_date":"20260803","center_classification_date":"20260930","report_date":"20261007","code_info":"Products containing affected software: Item Numbers / UDI-DI codes: Item Number: B96692 UDI-DI code: 14987666542965  Item Number: B96693 UDI-DI code: 14987666542972  Item Number: B12183 UDI-DI code: 14987666540671  Item Number: N3151400 UDI-DI code: Due to the age of the device and the fact that it has exceeded its storage period, the UDI number is not available.)","more_code_info":""}]}}