Beckman Coulter, Inc. recalls DxU 840m Iris

Recalling company

Beckman Coulter, Inc.

Product

DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 12, 2026

Reported

Oct 21, 2026

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.

Status

Ongoing

Quantity

2,088

Lot / codes

Product/UDI-DI: DxU 840m/15099590748654, DxU 850m/15099590748647. All Serial Numbers

Company location

Miami, FL

Recall type

Voluntary: Firm initiated

Recall number

Z-0160-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0160-2027 in the FDA Enforcement Report. Also see FDA recall press releases.