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DiaSorin Molecular LLC recalls MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detec
Recalled July 22, 2020 · FDA recall Z-2548-2020 · DiaSorin Molecular
Hazard
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. · FDA Class II
Units
405 plastic vials (24 vials per box)
Sold at
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.
Description
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).
Manufacturer(s)
DiaSorin Molecular LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →