Beckman Coulter recalls 2,088 DxU 840m Iris and DxU 850m Iris devices due to risk of lamina fluid leakage from a check valve not replaced annually. This may cause slips, chemical exposure, biohazards, or delayed patient results.
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.
✎ GovInfoNow plain-language explainer
Beckman Coulter is recalling 2,088 DxU 840m Iris and DxU 850m Iris devices because their rinse-line check valves may leak lamina fluid if not replaced annually. This could lead to slips, chemical exposure, biohazards, or delayed patient results. Read more at govinfonow.com/recall/1764904-beckman-coulter-inc-recalls-dxu-840m-iris-ref-c76947-dxu.
“Beckman Coulter DxU 840m Iris Recall: Annual Check Valve Replacement Needed.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764904-beckman-coulter-inc-recalls-dxu-840m-iris-ref-c76947-dxu. Based on FDA recall #Z-0160-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0160-2027%22&limit=1).
The FDA announced on August 12, 2026, that Beckman Coulter, Inc. is recalling DxU 840m Iris and DxU 850m Iris analyzers due to a rinse-line check valve defect. The hazard involves potential fluid leakage causing slip, chemical, or biohazard exposure.
How to tell if you have it
Brand: Beckman Coulter
Product: DxU 840m Iris, REF: C76947
Product: DxU 850m Iris, REF: C49513
Product/UDI-DI: DxU 840m/15099590748654
Product/UDI-DI: DxU 850m/15099590748647
Units affected: 2,088
The hazard
According to the FDA, the rinse-line check valve has a shorter service lifespan than expected and requires annual replacement to prevent lamina fluid leakage. The check valve replacement was excluded from annual preventive maintenance requirements without adequate reliability evaluation. When not replaced annually, the valve 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.
Context
GovInfoNow's records show Beckman Coulter, Inc. has had 134 other recalls since June 20, 2017. Recent similar product recalls include Medline Kits with Stuck Check Valve Recall (November 26, 2025) and Olympus Single Use Biopsy Valve Recall (January 29, 2026).
How to tell if you have this one
Check for the product model DxU 840m Iris or DxU 850m Iris with serial numbers listed in the recall notice. All units sold worldwide are affected.
Brand
Beckman Coulter
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Recall number
Product, codes & lots
Quantity
Z-0160-2027
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513; Product/UDI-DI: DxU 840m/15099590748654, DxU 850m/15099590748647. All Serial Numbers
Verify if the rinse-line check valve has been replaced annually as per the manufacturer's instructions.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0160-2027 (August 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0160-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.