Device recall
Z-1001-2020: Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS…
FDA device recall · Class II · Clinical Diagnostic Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-1001-2020 |
|---|---|
| Recall event | 84614 |
| Product | Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011 |
| Product code | GKZ |
| Recalling firm | Clinical Diagnostic Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 3, 2022 |
| 510(k) numbers | K083420 |
| FEI number | 3002684533 |
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