inforMED
InjuryPGI

QUEST INHIBITION ASSAY CONFIRMATORY HSV TEST

Received Dec 16, 2025 · Event occurred Oct 18, 2023

Report MW5180651 · MDR key 23827446

Device

Generic name

Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutane

Manufacturer

Quest Diagnostics

Product problems

  • False Positive Result
  • False Positive Result

Patient

31 YR · Male

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

Narrative

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED ON 4/22/2026 FOR REPORT MW5180651 TO UPDATE PROCODE TO PGI.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED ON 02/04/2026 FOR REPORT MW5180651 TO UPDATE DEVICE NAME AND MANUFACTURER.

Description of Event or Problem

PATIENT HAD A FALSE POSITIVE HSV-2 TEST RESULT. PATIENT TESTED POSITIVE FOR HSV-2 ON A DIASORIN LIAISON XL HSV-2 IGG TEST AT (B)(6). PATIENT ALSO TESTED POSITIVE ON QUEST INHIBITION ASSAY. PATIENT RECEIVED A CONFIRMATORY TEST VIA (B)(6) WHICH WAS INDETERMINATE. PT CODE: 4582. DEVICE CODE: 1227. REF REPORT: MW5180652.