{"recall":{"id":"fda-device-99436","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Beckman Coulter Inc. recalls 2 products","firm":"Beckman Coulter Inc.","date":"2026-07-15","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers","code":"1) Part Number C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331.","quantity":"","number":"Z-2973-2026","classification":"Class II"},{"name":"Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers","code":"1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065","quantity":"","number":"Z-2974-2026","classification":"Class II"}],"reason":"a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide.","nationwide":true,"states":[],"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=99436","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"574d82af6237118e","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=99436","record":[{"status":"Ongoing","city":"Brea","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99436","recalling_firm":"Beckman Coulter Inc.","address_1":"250 S Kraemer Blvd","address_2":"","postal_code":"92821-6232","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide.","recall_number":"Z-2973-2026","product_description":"Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower:    1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522;   2) DxC 500 AU Module, DxC 500i, Part Number C63521;   3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers","product_quantity":"","reason_for_recall":"a software defect in which the Parameter Package (PP)  import logic overwrites all predefined calculated test rules, including those previously  modified by the user, upon import of a new Parameter Package version. As a result, usercustomized  calculated test rules revert silently to their default expressions, potentially  generating erroneous patient test results without an explicit error notification. The issue affects  instruments running software version 1.5 or lower and only occurs when a new Parameter  Package is imported to a system that already has an existing Parameter Package onboard; new  installations are not affected.","recall_initiation_date":"20260715","center_classification_date":"20260817","report_date":"20260826","code_info":"1) Part Number C63522, UDI/DI 14987666545089;  2) Part Number C63521, UDI/DI 14987666545072;  3) Part Number C13252, UDI/DI 15099590742331.","more_code_info":""},{"status":"Ongoing","city":"Brea","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99436","recalling_firm":"Beckman Coulter Inc.","address_1":"250 S Kraemer Blvd","address_2":"","postal_code":"92821-6232","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide.","recall_number":"Z-2974-2026","product_description":"Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower:    1) AU w/out ISE, Part Number C63519;   2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers","product_quantity":"","reason_for_recall":"a software defect in which the Parameter Package (PP)  import logic overwrites all predefined calculated test rules, including those previously  modified by the user, upon import of a new Parameter Package version. As a result, usercustomized  calculated test rules revert silently to their default expressions, potentially  generating erroneous patient test results without an explicit error notification. The issue affects  instruments running software version 1.5 or lower and only occurs when a new Parameter  Package is imported to a system that already has an existing Parameter Package onboard; new  installations are not affected.","recall_initiation_date":"20260715","center_classification_date":"20260817","report_date":"20260826","code_info":"1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065","more_code_info":""}]}}