Z-2549-2020Class II

MOL3655 Simplexa VZV Swab Direct -

Name: Z-2549-2020 MOL3655 Simplexa VZV Swab Direct -
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 MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus... 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-2549-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-12
Posted: 2020-07-10
Terminated: 2024-04-19
Recalling firm: DiaSorin Molecular LLC
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.
Product code: PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
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: 304 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: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2549-2020
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 PGI

K192376Class IISimplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC / cleared 2019-11-26

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)