{"recall":{"id":"fda-device-99349","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":"2026-06-26","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument","code":"UDI: 15099590799243/ V5.03 Panel Update 11","quantity":"158 instruments","number":"Z-2888-2026","classification":"Class II"},{"name":"REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument","code":"UDI: 15099590799250/ V5.03 Panel Update 11","quantity":"","number":"Z-2889-2026","classification":"Class II"}],"reason":"Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.\"","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, \tVA, WI, WV, WY.","nationwide":true,"states":[],"units":"158 instruments","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=99349","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"26633b0454b2205e","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=99349","record":[{"status":"Ongoing","city":"Brea","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99349","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":"","distribution_pattern":"US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, \tVA, WI, WV, WY.","recall_number":"Z-2888-2026","product_description":"REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed  on the following instruments:   - B1018-280 MicroScan autoSCAN-4 Instrument  - B1018-283 MicroScan WalkAway-40 plus Instrument  - B1018-284 MicroScan WalkAway-96 plus Instrument  - B1018-440 DxM-1040 MicroScan WalkAway Instrument  - B1018-496 DxM-1096 MicroScan WalkAway Instrument","product_quantity":"158 instruments","reason_for_recall":"Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.\"","recall_initiation_date":"20260626","center_classification_date":"20260805","report_date":"20260812","code_info":"UDI: 15099590799243/ V5.03 Panel Update 11","more_code_info":""},{"status":"Ongoing","city":"Brea","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99349","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":"","distribution_pattern":"US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, \tVA, WI, WV, WY.","recall_number":"Z-2889-2026","product_description":"REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments:   - B1018-280 MicroScan autoSCAN-4 Instrument  - B1018-283 MicroScan WalkAway-40 plus Instrument  - B1018-284 MicroScan WalkAway-96 plus Instrument  - B1018-440 DxM-1040 MicroScan WalkAway Instrument  - B1018-496 DxM-1096 MicroScan WalkAway Instrument","product_quantity":"","reason_for_recall":"Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.\"","recall_initiation_date":"20260626","center_classification_date":"20260805","report_date":"20260812","code_info":"UDI: 15099590799250/ V5.03 Panel Update 11","more_code_info":""}]}}