{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-19", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "222606", "product_res_number": "Z-0160-2027", "event_date_initiated": "2026-08-12", "event_date_posted": "2026-10-15", "recall_status": "Open, Classified", "res_event_number": "99832", "product_code": "KQO", "k_numbers": [ "K210127", "K252580", "K022774" ], "product_description": "DxU 840m Iris, REF: C76947;\nDxU 850m Iris, REF: C49513", "code_info": "Product/UDI-DI: \nDxU 840m/15099590748654, DxU 850m/15099590748647.\n\nAll Serial Numbers", "firm_fei_number": "3000203293", "recalling_firm": "Beckman Coulter, Inc.", "address_1": "11800 Sw 147th Ave", "city": "Miami", "state": "FL", "postal_code": "33196-2500", "additional_info_contact": "Jennifer Chau\n916-857-6006", "reason_for_recall": "The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement\nto prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual\npreventive maintenance (PM) requirements without adequate reliability evaluation. When the check\nvalve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor,\npotentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure),\nbiohazardous exposure, property damage, and delayed patient results.", "root_cause_description": "Component design/selection", "action": "On 8/12/2026, recall notices were mailed and emailed to customers asking them to take the following actions:\n1) Perform the daily Cleaning Instrument Surfaces maintenance described in Chapter 12, Maintenance Procedure of the DxU 840/850m Instructions for Use (PN# C49320AB), (PN# D38676AA), or iQ200 Instructions for Use (PN# 300-4320CE), (PN# 300-4321EE). During the cleaning, inspect the instrument for signs of lamina leakage, including fluid accumulation on or around the instrument, or evidence of fluid on the laboratory bench or floor. If you determine that there is a leak, discontinue use of the analyzer and clean any spilled fluid in accordance with your laboratory's safety procedure.\n2) Contact the firm's Technical Support Organization immediately if evidence of leakage is observed.\n3) Continue routine operation, if no leakage is observed, while maintaining increased awareness for the symptoms described in the impact section of this letter.\n4) Post this letter on or near affected Analyzers.\n5) Share this information with laboratory staff and retain this notification. If you have forwarded any of the affected products to another laboratory, please provide them a copy of this letter.\n\nFirm is investigating this issue and will continue to address any reported lamina fluid leakage through its Technical Support Organization until this issue has been fully resolved.\n\nIf you have any questions regarding this notice, please contact the firm's Customer Support Center: http://www.beckmancoulter.com or 1-800-854-3633 in the United States and Canada.", "product_quantity": "2,088", "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.", "openfda": { "k_number": [ "K921087", "K761306", "K934042", "K813056", "K760472", "K101852", "K951877", "K140717", "K012829", "K842238", "K926359", "K031947", "K954156", "K946183", "K954024", "K960546", "K070929", "K972141", "K943463", "K932674", "K821738", "K830220", "K980047", "K053253", "K954514", "K093098", "K842237", "K142543", "K030600", "K841041", "K960054", "K954158", "K870526", "K935408", "K042421", "K141874", "K093555", "K051526", "K121456", "K840996", "K931602", "K091472", "K983510", "K943592", "K102188", "K013783" ], "registration_number": [ "3010564249", "3043138885", "2432235", "3007301207", "9615507", "9610126", "3013660430", "3024463179", "3042471840", "3003741796", "3003917514", "3033509895", "3015921024", "3043226252", "2122870", "1832216", "9680746", "3008987086", "3027225088", "3018771894", "3005360469", "3003422726", "1036362", "1649661", "1061932", "4580", "3013188547", "9611444", "9610633", "3003795116", "3006198300", "3014150341", "1832816", "3004875840", "3008058135", "3034731501", "3048141116", "2029372", "9710094", "3020704087", "3009238284", "3009448641", "3010891909", "2531491", "3002637618", "3031915160", "3006979678", "3038188172", "3010324880", "3027645317", "3043088937", "3038206980", "3008517993", "3043127699", "2030633", "3006479639", "3009495621", "1616487", "3015341499", "1181121", "3006621318", "1000369487", "3039396083", "1417592", "3012494290", "3005146144", "3013679502" ], "fei_number": [ "3010564249", "3043138885", "2432235", "3000210620", "3007301207", "3024463179", "3042471840", "3013660430", "3003741796", "3003917514", "3033509895", "3015921024", "3043226252", "2122870", "1832216", "3008987086", "3027225088", "3018771894", "3003422726", "1036362", "1000306617", "4580", "3013188547", "3003795116", "3006198300", "3014150341", "1832816", "3004875840", "3002829675", "3008058135", "3002806559", "3034731501", "3048141116", "3020704087", "3003516723", "3009238284", "3009448641", "3010891909", "3005670738", "3002637618", "3002806693", "3031915160", "3002807423", "3006979678", "3038188172", "3010324880", "3027645317", "3001451797", "3043088937", "3038206980", "3008517993", "3043127699", "3006479639", "3009495621", "1616487", "3015341499", "1000206808", "1181121", "3003347234", "3006621318", "3000203293", "1000369487", "3039396083", "1417592", "3012494290", "3005146144", "3013679502" ], "device_name": "Automated Urinalysis System", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2900", "device_class": "1" } } ] }