inforMED
MalfunctionMYF

BIOKIT HSV 2 TEST

Received Mar 6, 2023

Report MW5115471 · MDR key 16495878

Device

Generic name

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

Manufacturer

Biokit S.a.

Product problems

  • False Positive Result

Patient

45 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

FALSE POSITIVE HSV 2 ANTIBODY TESTS COMPARED TO THE HERPES WESTERN BLOT GOLD STANDARD. BIOKIT HSV 2 TEST ALSO POSITIVE. REFERENCE REPORT: MW5115470.