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Recall Observatory FDA recall evidence

Device 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).

Z-2548-2020

May 12, 2020

Class II

Product summary

Firm
DiaSorin Molecular LLC
Event
Event 85744
Status
Terminated
Classification
Class II
Quantity
405 plastic vials (24 vials per box)
Official record key
device-enforcement:Z-2548-2020

Official wording

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

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software malfunction