FDA Device recall Z-2548-2020
MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-z…
- FDA Device
- Class II
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class II recall of MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-z… by Diasorin Molecular, citing due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2548-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-12 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Diasorin Molecular |
| Distribution | US |
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).
Reason
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Identifiers
| code_info | MOL3650 Simplexa VZV Direct: Lot Numbers Release Date Exp Date 5178N 06/12/19 6/30/2020 7004…MOL3650 Simplexa VZV Direct: Lot Numbers Release Date Exp Date 5178N 06/12/19 6/30/2020 7004N 03/04/20 2/28/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2548-2020%22
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