Beckman Coulter, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1598-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 5, 2023

Date Posted: May 24, 2023

Recall Number: Z-1598-2023

Event ID: 92056

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 355 units

Code Information:

UDI/DI 15099590748654, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated