# FDA recall Z-1362-2018

> **Beckman Coulter Inc.** · Class II · device recall initiated 2018-03-02.

## Product

BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers:   700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370

## Reason for recall

Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting  per low-power field (/LPF)* or *per microliter.  This may occur during initial method validation or if settings are altered after the initial validation.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-1362-2018
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-02
- **Report date:** 2018-04-18
- **Termination date:** 2023-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1362-2018

## Citation

> AI Analytics. FDA recall Z-1362-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1362-2018. Source: US FDA. Licensed CC0.

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