Z-2547-2020Class II

MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs

Name: Z-2547-2020 MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs
Creator: DiaSorin Molecular LLC
Published: 2020-05-12
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2020-05-12 / Terminated / root cause: software

FDA source

DiaSorin Molecular LLC began a recall of 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... on 2020-05-12. FDA classified it as Class II and gives the reason as "Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2547-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-12
Posted: 2020-07-10
Terminated: 2024-04-19
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.
Product code: OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Reason for recall: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Root cause tag: software
FDA 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 [email protected] -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 [email protected]
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2547-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2547-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-10
Z-2548-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-10
Z-2549-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-10

Product code OQO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)