{"recall":{"id":"fda-device-99832","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":"2026-08-12","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513","code":"Product/UDI-DI: DxU 840m/15099590748654, DxU 850m/15099590748647. All Serial Numbers","quantity":"2,088","number":"Z-0160-2027","classification":"Class II"},{"name":"IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683","code":"Product/UDI-DI: IQ200 SPRINT/10837461001256, IQ200 SELECT/10837461001300, IQ200 ELITE/10837461001355. All Serial Numbers","quantity":"","number":"Z-0161-2027","classification":"Class II"}],"reason":"The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and the countries of Canada, Mexico, Switzerland, Panama, Ecuador, Japan, Hungary, Italy, Belgium, China, Germany, France, United Kingdom of Great Britain and Northern Ireland, Russian Federation, Singapore, Romania, Argentina, Israel, Spain, Belarus, Guatemala, Colombia, Qatar, Czechia, Reunion, Australia, United Arab Emirates, Poland, Croatia, Brazil, Slovakia, New Zealand, Saudi Arabia, Thailand, Republic of Korea, Serbia, Austria, Macao, Ukraine, India, Netherlands, Taiwan, South Africa, Sint Maarten, Bangladesh, Hong Kong, Viet Nam, Bahrain, Uganda, Lebanon, Morocco, Guadeloupe, Greece, Curacao, Republic of Moldova, Malaysia, Ghana, Indonesia, Lithuania, Portugal, Kazakhstan, Georgia, Philippines, Bosnia and Herzegovina, Libya, Kuwait, Oman, Jordan, Uzbekistan.","nationwide":true,"states":[],"units":"2,088","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=99832","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"460d851b72b49ff8","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=99832","record":[{"status":"Ongoing","city":"Miami","state":"FL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99832","recalling_firm":"Beckman Coulter, Inc.","address_1":"11800 Sw 147th Ave","address_2":"","postal_code":"33196-2500","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and the countries of Canada, Mexico, Switzerland, Panama, Ecuador, Japan, Hungary, Italy, Belgium, China, Germany, France, United Kingdom of Great Britain and Northern Ireland, Russian Federation, Singapore, Romania, Argentina, Israel, Spain, Belarus, Guatemala, Colombia, Qatar, Czechia, Reunion, Australia, United Arab Emirates, Poland, Croatia, Brazil, Slovakia, New Zealand, Saudi Arabia, Thailand, Republic of Korea, Serbia, Austria, Macao, Ukraine, India, Netherlands, Taiwan, South Africa, Sint Maarten, Bangladesh, Hong Kong, Viet Nam, Bahrain, Uganda, Lebanon, Morocco, Guadeloupe, Greece, Curacao, Republic of Moldova, Malaysia, Ghana, Indonesia, Lithuania, Portugal, Kazakhstan, Georgia, Philippines, Bosnia and Herzegovina, Libya, Kuwait, Oman, Jordan, Uzbekistan.","recall_number":"Z-0160-2027","product_description":"DxU 840m Iris, REF: C76947;  DxU 850m Iris, REF: C49513","product_quantity":"2,088","reason_for_recall":"The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement  to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual  preventive maintenance (PM) requirements without adequate reliability evaluation. When the check  valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor,  potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure),  biohazardous exposure, property damage, and delayed patient results.","recall_initiation_date":"20260812","center_classification_date":"20261015","report_date":"20261021","code_info":"Product/UDI-DI:  DxU 840m/15099590748654, DxU 850m/15099590748647.  All Serial Numbers","more_code_info":""},{"status":"Ongoing","city":"Miami","state":"FL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99832","recalling_firm":"Beckman Coulter, Inc.","address_1":"11800 Sw 147th Ave","address_2":"","postal_code":"33196-2500","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and the countries of Canada, Mexico, Switzerland, Panama, Ecuador, Japan, Hungary, Italy, Belgium, China, Germany, France, United Kingdom of Great Britain and Northern Ireland, Russian Federation, Singapore, Romania, Argentina, Israel, Spain, Belarus, Guatemala, Colombia, Qatar, Czechia, Reunion, Australia, United Arab Emirates, Poland, Croatia, Brazil, Slovakia, New Zealand, Saudi Arabia, Thailand, Republic of Korea, Serbia, Austria, Macao, Ukraine, India, Netherlands, Taiwan, South Africa, Sint Maarten, Bangladesh, Hong Kong, Viet Nam, Bahrain, Uganda, Lebanon, Morocco, Guadeloupe, Greece, Curacao, Republic of Moldova, Malaysia, Ghana, Indonesia, Lithuania, Portugal, Kazakhstan, Georgia, Philippines, Bosnia and Herzegovina, Libya, Kuwait, Oman, Jordan, Uzbekistan.","recall_number":"Z-0161-2027","product_description":"IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997;  IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684;  IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683","product_quantity":"","reason_for_recall":"The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement  to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual  preventive maintenance (PM) requirements without adequate reliability evaluation. When the check  valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor,  potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure),  biohazardous exposure, property damage, and delayed patient results.","recall_initiation_date":"20260812","center_classification_date":"20261015","report_date":"20261021","code_info":"Product/UDI-DI:  IQ200 SPRINT/10837461001256, IQ200 SELECT/10837461001300, IQ200 ELITE/10837461001355.  All Serial Numbers","more_code_info":""}]}}