Events

Recall of TOMCAT INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC 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
    89496
  • Event Risk Class
    III
  • Event Initiated Date
    2017-06-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Periodically fail sample processing due to e18-excessive sample volume errors. root cause has been attributed to no x-axis holding force during the pipettor homing routine which can cause incorrect homing of the pipettor z-axis. software anomaly shich in rare cases can impact the tomcat's pipettor arm causing the sample pipette tip position to offset slightly lower than normal.

Device

TOMCAT INSTRUMENT

Manufacturer

GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC INC.
  • Manufacturer Address
    SAN DIEGO
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC