Device recall
Z-2786-2018: Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity…
FDA device recall · Class III · Clarity Diagnostics Llc
Key facts
| Recall number (Z-number) | Z-2786-2018 |
|---|---|
| Recall event | 80535 |
| 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… |
| Product code | CDM |
| Recalling firm | Clarity Diagnostics Llc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 12, 2024 |
| 510(k) numbers | K061559 |
| FEI number | 3004043187 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database