Home / Recalls / DiaSorin Molecular LLC / Z-2549-2020

Z-2549-2020 Class II Terminated

Recalled by DiaSorin Molecular LLC — Cypress, CA

Recall Details

Product Type
Devices
Report Date
July 22, 2020
Initiation Date
May 12, 2020
Termination Date
April 19, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
304 plastic vials (24 vials per box)

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.

Distribution Pattern

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.

Code Information

MOL3655 Simplexa VZV Swab Direct: Lot Numbers Release Date Exp Date 5743N 09/11/19 9/30/2020 5819N 10/09/19 10/31/2020 5820N 02/14/20 2/28/2021

Other recalls by DiaSorin Molecular LLC

  • Z-2153-2023 Class II — Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Ampl (June 14, 2023)
  • Z-1209-2023 Class II — Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; wi (January 30, 2023)
  • Z-1210-2023 Class II — Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: (January 30, 2023)
  • Z-0457-2022 Class II — Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 (November 19, 2021)
  • Z-0162-2022 Class II — SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20 (September 23, 2021)
  • Z-2548-2020 Class II — MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON (May 12, 2020)
  • Z-2547-2020 Class II — MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Sw (May 12, 2020)