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Beckman Coulter recalls DxU 840m Iris, REF: C76947

What should I do?

Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.

What's the 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.

What's affected

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

Read the official FDA Enforcement Report ↗