Events

Recall of WASP (Walk Away Specimen Process) Instrument software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Copan Italia.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65923
  • Event Risk Class
    Class 3
  • Event Number
    Z-2131-2013
  • Event Initiated Date
    2013-08-09
  • Event Date Posted
    2013-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120967
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, microtiter diluting/dispensing - Product Code JTC
  • 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 regulatory.wasp@copanitalia.com.

Device

WASP (Walk Away Specimen Process) Instrument software
  • Model / Serial
    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.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
  • Product 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.
  • Manufacturer
    Copan Italia

Manufacturer

Copan Italia
  • Manufacturer Address
    Copan Italia, Via Perotti, 10, Brescia Italy
  • Manufacturer Parent Company (2017)
    Copan Italian Spa
  • Source
    USFDA