The Recall Desk
LowFDA (Devices)·Z-2786-2018·Announced 2018-08-22

Clarity 10SG Urinalysis Strips Recalled for Analyzer Incompatibility

Clarity Diagnostics is recalling specific lots of Clarity 10SG Urinalysis Strips because they lack a Canister Code Bar Code Label, making them incompatible with Clarity Urocheck 120 Urine Analyzers.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a functional incompatibility due to a missing label, not a direct safety hazard like contamination or injury.

Plain-English summary

Clarity Diagnostics LLC is recalling specific lots of Clarity 10SG Urinalysis Strips, Model # DTG-10SG. The recall involves 7,536 bottles of the product. The affected lot codes are URS7100027EX, URS7100140EX, and URS8010016EX.

The recall was initiated because the specific lots are not compatible for use in the Clarity Urocheck 120 Urine Analyzers due to a lack of a Canister Code Bar Code Label. The product is intended for professional use in near-patient and centralized laboratory locations for the qualitative and semi-quantitative detection of various analytes in urine.

The affected products were distributed worldwide, including nationwide in the United States in the states of Arizona, Massachusetts, South Carolina, and Washington, as well as in Austria. Consumers and healthcare professionals should stop using the affected lots and contact Clarity Diagnostics for further instructions.

The recalled product

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,
Manufacturer
Clarity Diagnostics Llc
Category
Medical Device — Diagnostic Test Strips
Hazard
Affected units
7,536

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model # DTG-10SG
  • Lot Codes: URS7100027EX
  • URS7100140EX and URS8010016EX.

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Related recalls

Same hazard · incompatibility

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