Device recall
Z-2257-2018: Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix…
FDA device recall · Class III · Quantimetrix Corporation
Key facts
| Recall number (Z-number) | Z-2257-2018 |
|---|---|
| Recall event | 80179 |
| Product | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK… |
| Product code | JJW |
| Recalling firm | Quantimetrix Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 27, 2021 |
| 510(k) numbers | K874890 |
| FEI number | 2020715 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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