---
title: "DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diag... — FDA record Z-1598-2023 | Is It on Recall"
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 carryov"
url: https://isitonrecall.com/recall/fda-device-z-1598-2023-dxu-840m-iris-urine-microscopy-analyzer-catalog-number-c76947-in-vitro-diagnostic-device-urine-analy/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis — FDA record Z-1598-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 5, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Beckman Coulter, Inc.
- **Quantity**: 355 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1598-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1598-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI/DI 15099590748654, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide Distribution

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: May 24, 2023
- **Recall initiation date**: Apr 5, 2023
- **Center classification date**: May 17, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1598-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Beckman Coulter Inc. records](https://isitonrecall.com/brand/beckman-coulter-inc/)