DiaSorin Molecular LLC: 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

Recalling firm

DiaSorin Molecular LLC

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.

Status

Terminated

Initiated

2020-05-12

Posted

2020-07-10

Terminated

2024-04-19

Reason

Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

Root cause

Under Investigation by firm

Action

On 05/12/2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION LETTER" with an acknowledgement form to customers and distributors via email to inform them of an internal observed issue associated with the use of their Multi-Assay Suite (MAS) featured in the software version 2.0 where it may incorrectly apply the thresholds of the first loaded assay to the analytes coupled with the same dye in the second assay resulting in false negative or false positive results. The firm is instructing customers to: -Immediately discontinue the use of the MAS feature and that the issue will be correct in the new Software Version 2.1 which is expected to be release in June 2020. -Fill out the Response Form and return by either: -fax (562) 240-6526 Attention: Technical Services -email to: technical info.molecular@diasorin.com -mail to: ATTN: Technical Services, 11331 Valley View Street, Cypress, CA 90630 -Forward this communication to all required individuals with their organization. For further assistance with evaluating assay runs or for any questions, to contact Technical Services at +1-5672-240-6500, option 3 or via email ts.molecular@DiaSorin.com

Quantity

13943 plastic vials (24 vials per box)

Distribution

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.

Lot, serial or model codes

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

510(k) numbers

["K141458","K150962"]

PMA numbers

not on file

Product code

OQO

Firm FEI

2023365

Firm city

Cypress

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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