DiaSorin Molecular LLC recalls MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use o

Recalled July 22, 2020 · FDA recall Z-2547-2020 · 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

13943 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

MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.

Manufacturer(s)

DiaSorin Molecular LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →