Class II — DiaSorin Molecular LLC
| Recalling firm | DiaSorin Molecular LLC |
|---|---|
| Registered facility | DiaSorin Molecular LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
| 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). |
| Quantity | 405 plastic vials (24 vials per box) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland. |
| Initiated | 2020-05-12 |
| Classified | 2020-07-10 |
| Terminated | 2024-04-19 |
| Recall number | Z-2548-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DiaSorin Molecular LLC (Z-2548-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85744/
Alerts for DiaSorin Molecular LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.