Company: DiaSorin Molecular LLC
Date of Enforcement Report: 7/22/2020
Class II
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.
Recall Number: Z-2547-2020
REASON
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
RECALLING FIRM/MANUFACTURER
DiaSorin Molecular LLC on 5/12/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13943 plastic vials (24 vials per box)
DISTRIBUTION
U.S. Nationwide and International