LIAISON HSV-2 TYPE SPECIFIC IGG

Additional Manufacturer Narrative

REVIEW OF THE INFORMATION REASONABLY KNOWN AT THE TIME OF REPORTING INDICATES THAT NO DEATH OR PATIENT INJURY, ILLNESS, LIFE THREATENING CONDITION, PERMANENT IMPAIRMENT, PERMANENT DAMAGE TO A BODY STRUCTURE, OR MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE OCCURRED (DEFINITION OF SERIOUS INJURY 21 CFR 803.3). DATA REVIEW, COMPLAINT HISTORY, AND TREND ANALYSIS FOR THE LIAISON® HSV-2 TYPE SPECIFIC IGG ASSAY DID NOT IDENTIFY EVIDENCE OF A PRODUCT QUALITY OR PERFORMANCE ISSUE. IF A FALSE POSITIVE WERE TO OCCUR, IT IS UNLIKELY TO CAUSE DEATH OR SERIOUS INJURY.THE MANUFACTURER IS CONSERVATIVELY SUBMITTING THIS REPORT.

Description of Event or Problem

DIASORIN RECEIVED A VOLUNTARY MEDWATCH REPORT ALLEGING A FALSE POSITIVE RESULT GENERATED BY THE DIASORIN LIAISON® XL HSV 2 IGG ASSAY PERFORMED BY AN EXTERNAL LABORATORY. ACCORDING TO THE REPORT, THE PATIENT TESTED POSITIVE BY THE LIAISON® XL HSV-2 TYPE SPECIFIC IGG ASSAY AND POSITIVE BY THE EXTERNAL LABORATORY'S INHIBITION ASSAY. CONFIRMATORY TEST (TEST TYPE AND SITE UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.

Description of Event or Problem

CONFIRMATORY TEST= (B)(4). BLOT TEST DATE (B)(6) 2024.