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SeraQuest

QUEST INTERNATIONAL, INC. · Model HSV Type 2 G · UDI-DI 00850487007555

MYF Prescription
10
510(k) clearances
337
Adverse events
2
Recalls
13
Facilities

Description

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Recalls

DateFirmReason
2023-12-13Diasorin Inc.DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specif
2021-02-08Siemens Healthcare Diagnostics, IncPotential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequen

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.