Events

Rappel de WASP (Walk Away Specimen Process) Instrument software

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Copan Italia.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    65923
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2131-2013
  • Date de mise en oeuvre de l'événement
    2013-08-09
  • Date de publication de l'événement
    2013-08-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120967
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Device, microtiter diluting/dispensing - Product Code JTC
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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
  • Description du dispositif
    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
  • Adresse du fabricant
    Copan Italia, Via Perotti, 10, Brescia Italy
  • Société-mère du fabricant (2017)
    Copan Italian Spa
  • Source
    USFDA