FDA-Device2020-07-22Class II
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).
DiaSorin Molecular LLC
Hazard
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Sold states
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.
Affected count
405 plastic vials (24 vials per box)
Manufactured in
11331 Valley View St, N/A, Cypress, CA, United States
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2548-2020Don't want to check this manually?
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