BEUDAMED
    FDA Adverse Event Other Summary report: N

    GS HBSAG CONFIRMATORY ASSAY 3.0

    MDR report key: 2194405 · Received July 27, 2011

    Report

    Report Number
    3022521-2011-00002
    Event Type
    Other
    Date Received
    July 27, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    LOM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A LABORATORY CALLED TO REPORT THAT THEY ARE USING THE GS HBSAG EIA 3.0 AND THEY HAVE HAD SEVERAL SAMPLES THAT HAVE BEEN REPEAT (B)(6) WITH THE ASSAY THAT DID NOT CONFIRM AS (B)(6) WHEN TESTED WITH THE GS HBSAG CONFIRMATORY ASSAY 3.0. THE LAB HAS BEEN PRE-DILUTING ALL SAMPLES 1:10 OR 1:100 BEFORE TESTING WITH THE CONFIRMATORY ASSAY. IF THEY OBTAIN A RESULT OF (B)(6) ON THE CONFIRMATORY TEST, THEN THEY REPORT THE SAMPLE AS NEGATIVE. THE PACKAGE INSERT FOR THE CONFIRMATORY ASSAY DOES NOT INDICATE THAT SAMPLES SHOULD BE DILUTED FOR THE ORIGINAL TESTING WITH THE CONFIRMATORY ASSAY, AND ONLY RECOMMENDS THAT HIGH TITER SPECIMENS BE DILUTED, AND TESTED AGAIN, IF THEY DO NOT CONFIRM AS (B)(6) ON INITIAL TESTING WITH THE CONFIRMATORY ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GS HBSAG CONFIRMATORY ASSAY 3.0 IVD, EIA LOM BIO-RAD LABORATORIES MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1