Reported Jul 22, 2020 · Terminated

MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use…

DiaSorin Molecular LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DiaSorin Molecular LLC · 11331 Valley View St · Cypress, CA · 90630-5366

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

Lot codes and dates: MOL2150 Simplexa HSV 1&2 DirectLot Numbers Release Date Exp Date
135 of 135 codes
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
Amount recalled: 13943 plastic vials (24 vials per box)

The agency filed one notice per product. You are reading one of them; the other 2 are below.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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