Device recall
Z-0640-2019: GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System…
FDA device recall · Class II · Advanced Instruments, LLC
Key facts
| Recall number (Z-number) | Z-0640-2019 |
|---|---|
| Recall event | 79584 |
| Product | GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from… |
| Product code | GKL |
| Recalling firm | Advanced Instruments, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 24, 2019 |
| 510(k) numbers | K152776 |
| FEI number | 1217058 |
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