---
title: "iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684... — FDA record Z-1596-2023 | 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-1596-2023-iq200-series-urine-microscopy-analyzer-a-iq-200-select-part-numbers-c10684-and-700-3345-b-iq-200-eli/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Num... — FDA record Z-1596-2023

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**: iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
- **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**: 1068 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1596-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1596-2023%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 | a) iQ 200 Select, Part Numbers C10684, UDI/DI 15099590695484 and 700-3345, UD/DI 10837461001300; b) iQ 200 Elite, Part Numbers C10683, UDI/DI 15099590697129 and 700-3375, UDI/DI 10837461001355; c) iQ200 Select 1500, Part Number 700-3347, UD/DI 10837461001317; d) iQ200 Sprint, Part Number 700-3325, UDI/DI 10837461001256; All analyzers with Windows 10, Software Version 8.1; |

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-1596-2023%22)

## Related records

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