# FDA recall Z-2786-2018

> **Clarity Diagnostics Llc** · Class III · device recall initiated 2018-06-22.

## Product

Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG    Product Usage:  Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine concentration. The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Clarity 10SG Urinalysis Reagent Strips (Urine) can be re

## Reason for recall

Clarity Diagnostics LLC discovered specific lots of  Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.

## Distribution

Worldwide Distribution - US Nationwide in the states of  AZ, MA, SC, WA. and the country of Austria.

## Key facts

- **Recall number:** Z-2786-2018
- **Recalling firm:** Clarity Diagnostics Llc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-22
- **Report date:** 2018-08-22
- **Termination date:** 2024-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boca Raton, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2786-2018

## Citation

> AI Analytics. FDA recall Z-2786-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2786-2018. Source: US FDA. Licensed CC0.

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