FDA recall Z-2547-2020

DiaSorin Molecular LLC · Class II · device

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.

Reason for recall

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

Distribution

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.

Key facts

Status
Terminated
Initiation date
2020-05-12
Report date
2020-07-22
Termination date
2024-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cypress, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2547-2020