{"url_path":"/fda/device/recalls/Z-2973-2026","section_key":"summary","section_title":"DEVICE Recall: Beckman Coulter Inc. — 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","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-15","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2973-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Beckman Coulter Inc."},"word_count":197,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2973-2026\n\n**Recalling firm:** Beckman Coulter Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-15\n**Report date:** 2026-08-26\n\n## Product\nBeckman 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\n\n## Reason\na 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.\n\n## Affected lots\n1) Part Number C63522, UDI/DI 14987666545089;  2) Part Number C63521, UDI/DI 14987666545072;  3) Part Number C13252, UDI/DI 15099590742331.\n\n## Distribution\nWorldwide distribution - US Nationwide."}