BEUDAMED
    FDA Adverse Event Summary report: N

    BIOKIT HSV-2 RAPID TEST

    MDR report key: 9693750 · Received February 10, 2020

    Report

    Report Number
    MW5092892
    Date Received
    February 10, 2020
    Manufacturer
    BIOKIT, SA
    Product Code
    LGC
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWENTY-ONE BLOOD SAMPLES THAT WERE (B)(6) FOR (B)(6) ON THE DIASORIN LIAISON HSV TEST WERE SUBMITTED TO (B)(6) FOR BIO KIT TEST. SIX OF THE SAMPLES WERE BIOKIT (B)(6): THE 6 BIOKIT (B)(6) SAMPLES WERE SENT FOR WESTERN BLOT TEST 4 WERE WB (B)(6) FOR (B)(6). I WAS WB (B)(6) FOR (B)(6) WAS WB INDETERMINATE FOR (B)(6). (B)(6) RATE FOR BIOKIT COMPARED TO WESTERN BLOT (RUN AT UNIVERSITY OF (B)(6)) WAS 66%. THE 6 BIOKIT SAMPLES WERE RUN AT (B)(6). DIASORIN LIAISON IS AN FDA-CLEARED SCREENING TEST FOR (B)(6) BY IMMUNOASSAY. WESTERN BLOT IS THE GOLD STANDARD FOR CONFIRMATION AND WAS RUN AT THE UNIVERSITY OF (B)(6) UROLOGY LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149972 BIOKIT HSV-2 RAPID TEST ENZYME LINKED IMMUNOABSORBENT ASSAY, HERPES SIMPLEX VIRUS, NON-SPECIFIC LGC BIOKIT, SA 3000 28001 B31915

    Patients

    Seq Age Sex Outcome Treatment
    1