DeviceClearance

Recall Z-2547-2020— DiaSorin Molecular LLC

Class II · Terminated

Class II FDA medical device recall by DiaSorin Molecular LLC, initiated 2020-05-12, terminated 2024-04-19. It names 2 FDA 510(k) clearances: K150962, K141458. 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: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results..

Recalling firm
DiaSorin Molecular LLC
Classification
Class II
Status
Terminated
Initiated
2020-05-12
Terminated
2024-04-19
Firm location
Cypress, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.