Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MOL3650 Simplexa VZV Direct - Product Usage: is intended for Recalled by DiaSorin Molecular LLC Due to Due to a software malfunction in the Multi...

Date: May 12, 2020
Company: DiaSorin Molecular LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DiaSorin Molecular LLC directly.

Affected Products

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)

Why Was This Recalled?

Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About DiaSorin Molecular LLC

DiaSorin Molecular LLC has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report