Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Microbiology · 21 CFR 866.3309
For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.
Recent MDR events
37 adverse event reports on file
- QUEST INHIBITION ASSAYDec 17, 2025InjuryQuest DiagnosticsMW5180717
- QUEST INHIBITION ASSAY CONFIRMATORY HSV TESTDec 16, 2025InjuryQuest DiagnosticsMW5180593
- QUEST INHIBITION ASSAY CONFIRMATORY HSV TESTDec 16, 2025InjuryQuest DiagnosticsMW5180595
- QUEST INHIBITION ASSAY CONFIRMATORY HSV TESTDec 16, 2025InjuryQuest DiagnosticsMW5180597
- QUEST INHIBITION ASSAY CONFIRMATORY HSV TESTDec 16, 2025InjuryQuest DiagnosticsMW5180599
- QUEST INHIBITION ASSAY CONFIRMATORY HSV TESTDec 16, 2025InjuryQuest DiagnosticsMW5180601
- QUEST INHIBITION ASSAYDec 16, 2025InjuryQuest DiagnosticsMW5180603
- QUEST INHIBITION ASSAYDec 16, 2025InjuryQuest DiagnosticsMW5180605
- QUEST INHIBITION ASSAYDec 16, 2025InjuryQuest DiagnosticsMW5180607
- E1-QUEST INHIBITION ASSAYDec 16, 2025InjuryQuest DiagnosticsMW5180609
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- DiaSorin Molecular LLCTerminatedJul 10, 2020
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
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Z-2549-2020 · View FDA record ↗ - Luminex CorporationOpen, ClassifiedAug 15, 2019
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Z-2283-2019 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
Diasorin Molecular Llc
CYPRESS, CA, US
Biogx
Birmingham, AL, US
Abbott Molecular Distribution Center
Itasca, IL, US
Quidel Corp.
SAN DIEGO, CA, US
Acro Biotech Inc.
Montclair, CA, US
Meridian Bioscience, Inc.
Cincinnati, OH, US
Ortho-clinical Diagnostics, Inc.
ATHENS, OH, US
Elitechgroup Mdx Llc.
Bothell, WA, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Elitechgroup S.p.a.
Torino Piedmont, IT
Abbott Molecular, Inc.
Des Plaines, IL, US
510(k) clearances
9 clearances for this product code
- Abbott Molecular, Inc.May 3, 2024
K233349 · Alinity m HSV 1 & 2 / VZV
- Quidel CorporationDec 20, 2023
K232286 · Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- Diasorin Molecular, LLCNov 26, 2019
K192376 · Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
- ElitechgroupOct 29, 2018
K180559 · HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
- Diasorin Molecular, LLCMar 14, 2018
K173798 · Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- Quidel CorporationNov 28, 2016
K162451 · Solana HSV 1+2/VZV Assay
- Luminex CorporationOct 6, 2015
K151906 · ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
- Meridian Bioscience, Inc.Jul 17, 2015
K151046 · illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10