Clarity Urocheck 10SG Urinalysis Strips — Class III medical device recall Z-2786-2018
Terminated recall by Clarity Diagnostics Llc, reported 2018-08-22, distributed nationwide. Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clar
| Recall number | Z-2786-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clarity Diagnostics Llc, Boca Raton, FL, United States |
| Recall initiated | 2018-06-22 |
| Classified | 2018-08-11 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2024-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT |
| Quantity | 7,536 bottles |
| Reason classes | labeling |
| Lot numbers | URS7100027EX, URS7100140EX, URS8010016EX |
| Model numbers | DTG-10SG |
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 read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2786-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.