FDA-Device2026-10-21Class IIPROCESSING DEFECT

Beckman Coulter DxU 840m and 850m Iris analyzers recalled for lamina fluid leakage risk

OTHERNationwide distributionMedical devices

What this means

The rinse-line check valve in these laboratory analyzers wears out faster than expected and needs to be replaced every year. Because annual replacement was not included in the standard maintenance schedule, the valve can fail and allow lamina fluid to leak onto the work surface or floor. This creates risks of slips, falls, chemical exposure, and exposure to biological hazards.

Contact Beckman Coulter to confirm if your DxU 840m or 850m Iris analyzer is affected (check your serial number).
Have the rinse-line check valve replaced annually as part of preventive maintenance.
Report any fluid leaks or equipment malfunctions to Beckman Coulter immediately.

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The agency's original wording

Hazard

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

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.

Affected count

2,088

Manufactured in

11800 Sw 147th Ave, Miami, FL, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2027

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