Events

Recall of Peloris II Rapid Tissue Processor

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

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
    58502
  • Event Risk Class
    Class 2
  • Event Number
    Z-2597-2011
  • Event Initiated Date
    2011-04-11
  • Event Date Posted
    2011-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99479
  • 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
    Automated tissue processor. - Product Code IEO
  • Reason
    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
  • Model / Serial
    catalog number 26.0005, serial numbers 0265050B, 0265051B, 0265053B, 0265054B, 0265055B, 0265056B, 0265057B, 0265058B, 0265059B, 0265060B, 0265061B, 0265063B, 0265064B, 0265067B, 0265068B, 0265071B and 0265072B.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Australia, Canada, Germany Japan, Portugal and United Kingdom.
  • Product Description
    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.
  • Manufacturer Address
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA