Device recall
Z-2547-2020: MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous…
FDA device recall · Class II · DiaSorin Molecular LLC
Key facts
| Recall number (Z-number) | Z-2547-2020 |
|---|---|
| Recall event | 85744 |
| Product | MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs… |
| Product code | OQO |
| Recalling firm | DiaSorin Molecular LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2024 |
| 510(k) numbers | K141458, K150962 |
| 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