Recall – Multi Assay false negative results due to software error

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

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