Device recall
Z-2548-2020: MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON…
FDA device recall · Class II · DiaSorin Molecular LLC
Key facts
| Recall number (Z-number) | Z-2548-2020 |
|---|---|
| Recall event | 85744 |
| Product | MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS). |
| Product code | PLO |
| Recalling firm | DiaSorin Molecular LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2024 |
| 510(k) numbers | K190219 |
| FEI number | 2023365 |
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