BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-TEK AUTOMATED MICROPLATE READER

    MDR report key: 579101 · Received February 24, 2005

    Report

    Report Number
    1823260-2005-00288
    Event Type
    Malfunction
    Date Received
    February 24, 2005
    Date of Event
    January 27, 2005
    Report Date
    February 15, 2005
    Manufacturer
    BIO-TEK INSTRUMENTS, INC.
    Product Code
    JJQ
    Removal / Correction Number
    1823260-01/27/05-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN INTERNAL REVIEW, IT WAS DETERMINED THAT THE PRE-PROGRAMMED PARAMETERS FOR THE BIO-TEK AUTOMATED MICROPLATE READER CONTAINS INCORRECT PARAMETERS OF HEPAITIS C VIRUS (HCV) TEST VERSION 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TEK AUTOMATED MICROPLATE READER GENERAL PURPOSE INSTRUMENT JJQ BIO-TEK INSTRUMENTS, INC. ELX 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA