Events

Recall of Device Recall Peloris 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
    54566
  • Event Risk Class
    Class 2
  • Event Number
    Z-1551-2010
  • Event Initiated Date
    2010-02-09
  • Event Date Posted
    2010-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88794
  • 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
    Processor, tissue, automated - Product Code IEO
  • Reason
    Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve leakage have contributed to tissue damage during processing, leading to rebiopsies.
  • Action
    Leica Microsystems sent Medical Device Correction letters dated 2/9/10 to the affected customers via first class mail on the same date, informing them of the potential for tissue damage during processing and outlining the software upgrade being made to minimize the risk of tissue damage. Customers were informed that their local Leica Microsystems representative will contact them to arrange the software upgrade and to provide training on the use of the new software. The letters also provided the necessary steps required to avoid tissue damage during processing while they are awaiting the software upgrade. 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

Device Recall Peloris Rapid Tissue Processor
  • Model / Serial
    catalog number 26.0001 and 26.0005, serial numbers 0260001B to 0260341B, 0260344B, 0260346B to 0260353B, and 0260356B to 0260366B.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia.
  • Product Description
    Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Manufacturer Address
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA