DiaSorin Molecular LLC: Medical Device Recall in 2020 - (Recall #: Z-2548-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 12, 2020

Date Posted: July 22, 2020

Recall Number: Z-2548-2020

Event ID: 85744

Reason for Recall:

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

Status: Terminated

Product Quantity: 405 plastic vials (24 vials per box)

Code Information:

MOL3650 Simplexa VZV Direct: Lot Numbers Release Date Exp Date 5178N 06/12/19 6/30/2020 7004N 03/04/20 2/28/2021

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated