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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Clarity Diagnostics Llc
- 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
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