Class III — Clarity Diagnostics Llc
| Recalling firm | Clarity Diagnostics |
|---|---|
| Registered facility | Clarity Diagnostics, LLC (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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. |
| 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 assi… |
| Quantity | 7536 Bottles |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, MA, SC, WA. and the country of Austria. |
| Initiated | 2018-06-22 |
| Classified | 2018-08-11 |
| Terminated | 2024-01-12 |
| Recall number | Z-2786-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Clarity Diagnostics Llc (Z-2786-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80535/
Alerts for Clarity Diagnostics
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.