Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 11800 Sw 147th Ave · Miami, FL · 33196-2500
Is this the product you have?
- DxU 840m Iris
- REF
C76947DxU 850m Iris
- REFC49513
- Lot codes and dates
- Product/UDI-DI
DxU 840m/15099590748654DxU 850m/15099590748647. All Serial Numbers
- Product/UDI-DI
- Amount recalled
- 2,088
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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