CLASS II Device recall · Reported 22 Jul 2020 · FDA Enforcement Report

MOL3655 Simplexa VZV Swab Direct recalled by DiaSorin Molecular

DiaSorin Molecular is recalling MOL3655 Simplexa VZV Swab Direct, distributed nationwide in the US. The recall was initiated on 12 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMOL3655 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

Quantity recalled304 plastic vials (24 vials per box)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2549-2020
FDA event ID: 85744
Recalling firm: DiaSorin Molecular, Cypress, CA
Classification: Class II
Status: Terminated
Recall initiated: 12 May 2020
FDA classified: 10 Jul 2020
Reported: 22 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

12 May 2020	Recall initiated by company
10 Jul 2020	Classified by FDA	+59 days
22 Jul 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Colorado Florida Kansas Michigan North Carolina Pennsylvania Texas Washington

Questions about this recall

Is MOL3655 Simplexa VZV Swab Direct recalled?

Yes. DiaSorin Molecular recalled MOL3655 Simplexa VZV Swab Direct on 12 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2549-2020.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from DiaSorin Molecular

All 8

Reported	Class	Recall	Company	Reason	Where
26 Jul 2023Device	CLASS II	Simplexa Direct Amplification Disc Kit recalled by DiaSorin Molecular	DiaSorin Molecular	Packaging Defects	Nationwide
15 Mar 2023Device	CLASS II	Simplexa Flu A/B & RSV Direct Gen II recalled by DiaSorin Molecular	DiaSorin Molecular	Potency & Assay	Nationwide
15 Mar 2023Device	CLASS II	Simplexa Covid-19 Direct recalled by DiaSorin Molecular	DiaSorin Molecular	Potency & Assay	Nationwide
12 Jan 2022Device	CLASS II	Simplexa Direct Amplification Disc Kit, Product Kit recalled	DiaSorin Molecular	Packaging Defects	41 states
27 Oct 2021Device	CLASS II	Simplexa Covid-19 Positive Control Pack recalled by DiaSorin Molecular	DiaSorin Molecular	Other	Nationwide

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