Device recall
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
- Recall number
- Z-0160-2027
- Event id
- 99832
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Report date
- Oct 21, 2026
- Posted
- Oct 15, 2026
- Initiated
- Aug 12, 2026
- Center classification date
- Oct 15, 2026
- Product code
- KQO
- Device type
- Automated Urinalysis System
- 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.
- Root cause
- Component design/selection
- Quantity
- 2,088
- Code info
- Product/UDI-DI: DxU 840m/15099590748654, DxU 850m/15099590748647. All Serial Numbers
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Miami, FL, United States