{"recall":{"id":"fda-device-99800","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":"2026-09-02","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252","code":"Software version 1.3.5 or earlier. 1. UDI-DI 14987666545089 2. UDI-DI 14987666545072 3. UDI-DI 15099590742331","quantity":"146 US, 170 OUS","number":"Z-0083-2027","classification":"Class II"},{"name":"DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520","code":"Software version 1.4.5 or earlier. 1. UDI-DI 14987666545058 2. UDI-DI 14987666545065","quantity":"146 US, 170 OUS","number":"Z-0084-2027","classification":"Class II"}],"reason":"Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results. Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution.","nationwide":true,"states":[],"units":"146 US, 170 OUS; 146 US, 170 OUS","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=99800","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"63ee116e23647f3b","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=99800","record":[{"status":"Ongoing","city":"Brea","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99800","recalling_firm":"Beckman Coulter Inc.","address_1":"250 S Kraemer Blvd","address_2":"N/A","postal_code":"92821-6232","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-0083-2027","product_description":"DxC 500i Clinical Analyzer Modules:    1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522    2. DxC 500 AU Module, DxC 500i, Part No. C63521    3. Access 2 Module, DxC 500i, Part No. C13252","product_quantity":"146 US, 170 OUS","reason_for_recall":"Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does  Pre-Review Reminders  Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued).  Post-Review Reminders  Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature.  Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act.  Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan.  [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key.  Doc ID 03534.05.06 2 of 8  not provide a warning or notification to alert the user that the configured units have reverted to  the default units. This issue can result in falsely elevated reported results.","recall_initiation_date":"20260902","center_classification_date":"20261002","report_date":"20261014","code_info":"Software version 1.3.5 or earlier.  1. UDI-DI 14987666545089  2. UDI-DI 14987666545072  3. UDI-DI 15099590742331"},{"status":"Ongoing","city":"Brea","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99800","recalling_firm":"Beckman Coulter Inc.","address_1":"250 S Kraemer Blvd","address_2":"N/A","postal_code":"92821-6232","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-0084-2027","product_description":"DxC 500 AU Clinical Chemistry Analyzers:    1. AU w/out ISE, Part No. C63519    2. AU w/ISE, Part No. C63520","product_quantity":"146 US, 170 OUS","reason_for_recall":"Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does  Pre-Review Reminders  Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued).  Post-Review Reminders  Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature.  Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act.  Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan.  [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key.  Doc ID 03534.05.06 2 of 8  not provide a warning or notification to alert the user that the configured units have reverted to  the default units. This issue can result in falsely elevated reported results.","recall_initiation_date":"20260902","center_classification_date":"20261002","report_date":"20261014","code_info":"Software version 1.4.5 or earlier.  1. UDI-DI 14987666545058  2. UDI-DI 14987666545065"}]}}