Beckman Coulter, Inc. recalls DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

Recalled May 24, 2023 · FDA recall Z-1598-2023 · Beckman Coulter

Hazard

Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated. · FDA Class II

Units

355 units

Sold at

Worldwide Distribution

Description

Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

Product

DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

Manufacturer(s)

Beckman Coulter, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →