# FDA recall Z-2547-2020

> **DiaSorin Molecular LLC** · Class II · device recall initiated 2020-05-12.

## 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 for recall

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

## 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.

## Key facts

- **Recall number:** Z-2547-2020
- **Recalling firm:** DiaSorin Molecular LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-12
- **Report date:** 2020-07-22
- **Termination date:** 2024-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cypress, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2547-2020

## Citation

> AI Analytics. FDA recall Z-2547-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2547-2020. Source: US FDA. Licensed CC0.

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