BEUDAMED
    FDA Enforcement Class III Terminated

    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.

    Recall: Z-2131-2013 · Reported September 11, 2013

    Enforcement

    Recall Number
    Z-2131-2013
    Event ID
    65923
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Copan Italia
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2013
    Initiation Date
    August 9, 2013
    Classification Date
    August 30, 2013
    Termination Date
    December 12, 2013
    Address
    Via Perotti, 10, N/A, Brescia, N/A, N/A, Italy

    Description

    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.

    Reason

    The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk of rotation of the broth table when the door is open.

    Code Info

    Serial Numbers: W086-61-084/106/115/119/134/136; W086-050-179; W086-61-087/109/125/127/130/133; W086-050-144/151/153/157/170/171/181/184; W086-61-088/097/100/117; W086-050-177/178/183; W086-61-093; W086-050-143/155; W086-61-096; W086-050-164/169/159/175; W086-61-103/137/141/142; W08661-104/114118/128/138; W086050-182; W08661 111; W08661 113; W08661 124; W08661129/140; W086050150/152/154/185; W08661 139; W086050 147; W08661 110; W086050160/161/162; W086050 180; W086050 187.

    Distribution

    Worldwide Distribution - USA including Oregon and California., and the countries of France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan

    Quantity

    63 units