Events

Rappel de Peloris II Rapid Tissue Processor

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 Leica Microsystems, Inc..

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
    58502
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2597-2011
  • Date de mise en oeuvre de l'événement
    2011-04-11
  • Date de publication de l'événement
    2011-06-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99479
  • 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
    Automated tissue processor. - Product Code IEO
  • Cause
    The processor potentially has a faulty impellor which could lead to reagent carry-over from one processing step to another,.
  • Action
    Leica Microsystems sent a MEDICAL DEVICE CORRECTION letter dated April 11, 2011, to the affected customers via first class mail. The letter identified the product, the problem, and the action needed to be taken by the customer. The Customers were instructed to discontinue use of the device until their local Leica Microsystems representative contact them to arrange the replacement of the faulty impellor. The accounts were asked to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.

Device

Peloris II Rapid Tissue Processor
  • Modèle / numéro de série
    catalog number 26.0005, serial numbers 0265050B, 0265051B, 0265053B, 0265054B, 0265055B, 0265056B, 0265057B, 0265058B, 0265059B, 0265060B, 0265061B, 0265063B, 0265064B, 0265067B, 0265068B, 0265071B and 0265072B.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Australia, Canada, Germany Japan, Portugal and United Kingdom.
  • Description du dispositif
    Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0005. || This tissue processor prepares tissue samples for sectioning by transforming fixed samples into wax embedded samples. This is achieved by exposing the tissue samples to a sequence of reagents in the processing retorts.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Adresse du fabricant
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA