Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Microbiology · 21 CFR 866.3305
Recent MDR events
337 adverse event reports on file
- ALINITY I HSV-2 IGGMar 13, 2026MalfunctionAbbott Ireland Diagnostics Division3008344661-2026-00054
- LIAISON HSV-2 TYPE SPECIFIC IGGMar 4, 2026InjuryDiasorin Inc.2182595-2026-00021
- LIAISON HSV-2 TYPE SPECIFIC IGGMar 4, 2026InjuryDiasorin Inc.2182595-2026-00022
- LIAISON HSV-2 TYPE SPECIFIC IGGMar 4, 2026InjuryDiasorin Inc.2182595-2026-00023
- LIAISON HSV-2 TYPE SPECIFIC IGGMar 4, 2026InjuryDiasorin Inc.2182595-2026-00024
- LIAISON HSV-2 TYPE SPECIFIC IGGMar 4, 2026InjuryDiasorin Inc.2182595-2026-00025
- LIAISON HSV-2 TYPE SPECIFIC IGGFeb 6, 2026InjuryDiasorin, Inc.2182595-2026-00011
- LIAISON HSV-2 TYPE SPECIFIC IGGFeb 6, 2026InjuryDiasorin Inc2182595-2026-00001
- LIAISON HSV-2 TYPE SPECIFIC IGGFeb 6, 2026InjuryDiasorin, Inc.2182595-2026-00012
- LIAISON HSV-2 TYPE SPECIFIC IGGFeb 6, 2026InjuryDiasorin, Inc.2182595-2026-00014
Event type breakdown
Recalls
2 recall events for this product code
- Diasorin Inc.Open, ClassifiedJan 25, 2024
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.
Z-0815-2024 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedMar 18, 2021
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.
Z-1274-2021 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
Diasorin Inc.
Stillwater, MN, US
Biokit S.a.
LLISSA D AMUNT Barcelona, ES
Zeus Scientific Llc
BRANCHBURG, NJ, US
Diasorin Molecular Llc
CYPRESS, CA, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Trinity Biotech Usa
Jamestown, NY, US
Bio-rad Laboratories, Inc.
Hercules, CA, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Abbott Laboratories
Lake Forest, IL, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Arlington Scientific, Inc.
SPRINGVILLE, UT, US
Abbott Ireland
SLIGO, IE
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
510(k) clearances
10 clearances for this product code
- Biokit, S.A.Feb 12, 2025
K243575 · ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
- Roche DiagnosticsOct 12, 2022
K220924 · Elecsys HSV-2 IgG (08948887160)
- Quest International, Inc.Jun 13, 2019
K181514 · SeraQuest HSV Type 2 Specific IgG
- Biokit, S.A.Aug 23, 2018
K181334 · ADVIA Centaur Herpes-2 IgG
- Quest International, Inc.May 13, 2016
K152353 · SeraQuest HSV Type 2 Specific IgG
- Zeus Scientific, Inc.May 20, 2011
K103603 · ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
- DiaSorin, Inc.Nov 10, 2008
K081687 · LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
- Euroimmun Us, LLCJun 28, 2007
K061239 · EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT