Device recall
Z-2173-2024: Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and…
FDA device recall · Class II · SIGHT DIAGNOSTICS LTD
Key facts
| Recall number (Z-number) | Z-2173-2024 |
|---|---|
| Recall event | 94678 |
| Product | Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer. |
| Product code | GKZ |
| Recalling firm | SIGHT DIAGNOSTICS LTD |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190898 |
| FEI number | 3016099075 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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