BEUDAMED
    FDA Recall 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 · Initiated August 9, 2013

    Recall

    Recall Number
    Z-2131-2013
    Event Number
    65923
    Firm
    Copan Italia Via Perotti, 10 Brescia Italy
    FEI Number
    3002444944
    Product Code
    JTC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 9, 2013
    Posted
    August 30, 2013
    Terminated
    December 12, 2013

    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.

    Action

    Copan sent an Urgent WASP recall letter dated July 31, 2013, to all affected customers that received the WASP (Walk Away Specimen Process) instrument to notify them of the software upgrade 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. This event may happen only if damage in the door locking system happens. This could result in a minor, transient injury to the user due to the impact with the rotating table. The WASP instruments involved in this upgrade are all whose serial numbers show the configuration with the broth inoculation feature activated. The machine installed in your laboratory is one of this serial number involved in the SW upgrade. The Software upgrade will be performed on site by personnel trained by Copan and no action is required by yourself. Customers will be contacted by the WASP Technical Support in order to define a date that will fit with their planning. Customers with questions are instructed to call +39 0303666130 or write to [email protected].

    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