# FDA recall Z-0301-2019

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2018-09-24.

## Product

Roche Diagnostics URISYS 1100 Urine Analyzer  Part Number: 03617556001    Product Usage:  The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood

## Reason for recall

Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were higher than what is listed in the test strip method sheets may lead to false negative results for the affected parameters

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0301-2019
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-24
- **Report date:** 2018-11-07
- **Termination date:** 2022-02-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0301-2019

## Citation

> AI Analytics. FDA recall Z-0301-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0301-2019. Source: US FDA. Licensed CC0.

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