Recall Z-2549-2020— DiaSorin Molecular LLC

Name: FDA recall Z-2549-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-12

Class II · Terminated

Class II FDA medical device recall by DiaSorin Molecular LLC, initiated 2020-05-12, terminated 2024-04-19. It names one FDA 510(k) clearance: K192376. Product: MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.. 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

1 on FDA's record

K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC·cleared 2019-11-26

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

MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.

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.