Clarity Diagnostics Llc recalls Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine)…

Recall date

June 22, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2786-2018

FDA classification

Class III

Brand / firm

Clarity Diagnostics Llc

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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 read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.