FDA Device recall Z-2547-2020
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX i…
- FDA Device
- Class II
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class II recall of MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX i… by Diasorin Molecular, citing due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2547-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-12 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Diasorin Molecular |
| Distribution | US |
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.
Reason
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Identifiers
| code_info | MOL2150 Simplexa HSV 1&2 Direct: Lot Numbers Release Date Exp Date 3606N 08/16/18 6/30/2020…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2547-2020%22
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