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Medical Device

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

Recall date: 2026-10-21 · Source: FDA_DEVICE
Brand / Firm
Beckman Coulter, Inc.
Product
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Reason for recall
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.
Units affected
2,088
Description
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
View official recall notice →