Home / Recalls / DiaSorin Molecular LLC / Z-2547-2020

Z-2547-2020 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
13943 plastic vials (24 vials per box)

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.

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

MOL2150 Simplexa HSV 1&2 Direct: Lot Numbers Release Date Exp Date 3606N 08/16/18 6/30/2020 3607N 08/31/18 6/30/2020 3609N 08/31/18 6/30/2020 3610N 10/08/18 7/31/2020 3615N 01/07/19 6/30/2020 3616N 11/28/18 6/30/2020 3618N 12/26/18 6/30/2020 3619N 12/26/18 6/30/2020 3847N 12/31/18 6/30/2020 3998N 07/20/18 5/31/2020 4000N 07/18/18 5/31/2020 4130N 03/05/19 6/30/2020 4131N 02/01/19 6/30/2020 4132N 02/15/19 6/30/2020 4134N 04/18/19 8/31/2020 4137N 04/04/19 8/30/2020 4138N 04/30/19 8/31/2020 4139N 07/12/19 5/31/2021 5171N 09/17/19 6/30/2021 5172N 09/03/19 6/30/2021 5173N 05/03/19 8/31/2020 5174N 06/04/19 8/31/2020 5175N 06/04/19 8/31/2020 5187N 07/19/19 5/31/2021 5188N 06/05/19 8/31/2020 5189N 07/25/19 5/31/2021 5190N 05/23/19 8/31/2020 5623N 07/25/19 5/31/2021 5738N 08/02/19 5/31/2021 5739N 08/20/19 6/30/2021 5793N 10/07/19 7/31/2021 5795N 03/09/20 12/31/2021 5841N 10/22/19 8/31/2021 5843N 10/31/19 8/31/2021 5845N 10/18/19 8/31/2021 5846N 04/06/20 1/31/2022 5846NA 04/16/20 1/31/2022 5847N 12/17/19 10/31/2021 5878N 03/11/20 1/31/2022 5888N 03/18/20 1/31/2022 R5170N 06/20/19 8/31/2020 R5201N 06/28/19 8/31/2020 R5202N 07/03/19 4/30/2021 R5283N 08/13/19 8/31/2020 R5285N 06/20/19 8/31/2020

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-2549-2020 Class II — MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIA (May 12, 2020)