LIAISON HSV-2 TYPE SPECIFIC IGG

Description of Event or Problem

(B)(4). BLOT TEST DATE (B)(6) 2023.

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). THE MANUFACTURER PREVIOUSLY IDENTIFIED A DEVICE PERFORMANCE ISSUE ASSOCIATED WITH INCREASED EQUIVOCAL AND FALSE POSITIVE HSV-2 IGG RESULTS AFFECTING A SUBSET OF PRODUCT LOTS MANUFACTURED PRIOR TO DECEMBER 2023. CORRECTIVE ACTIONS WERE IMPLEMENTED THROUGH THE CAPA SYSTEM, AND A CLASS II RECALL WAS INITIATED ON DECEMBER 13, 2023 TO REMOVE AND REPLACE AFFECTED LOTS. THE LOT NUMBER ASSOCIATED WITH THIS EVENT IS UNKNOWN. BECAUSE THE REPORTED EVENT DATE MAY OVERLAP WITH THE PERIOD DURING WHICH RECALLED LOTS REMAINED IN DISTRIBUTION, INVOLVEMENT OF AN AFFECTED LOT CANNOT BE DEFINITIVELY RULED OUT. WHILE RECURRENCE OF THIS ISSUE IS UNLIKELY TO RESULT IN DEATH OR SERIOUS INJURY, THIS REPORT IS BEING CONSERVATIVELY SUBMITTED.

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. WESTERN BLOT (TEST LABORATORY UNKNOWN) WAS NEGATIVE. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.