FDA-Device2020-07-22Class II
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.
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
304 plastic vials (24 vials per box)
Manufactured in
11331 Valley View St, N/A, Cypress, CA, United States
Products
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2549-2020Don't want to check this manually?
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