Events

Recall of AUTOMATE 2500 SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    101142
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-19
  • 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
    Beckman coulter has identified a rare potential issue with the tip present sensor within the robot of the aliquoter module. there has been one report of a misaligned sensor in an automate system which resulted in the system processing samples without pipette tips. a small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. in this particular case the system gave no external sign of a misaligned tip present sensor.

Device

AUTOMATE 2500 SYSTEM
  • Model / Serial
    Model Catalog: ODL25255 (Lot serial: ODL25255-4546); Model Catalog: ODL25255 (Lot serial: ODL25255-4344); Model Catalog: ODL25125 (Lot serial: ODL25255-4344); Model Catalog: ODL25125 (Lot serial: ODL25255-4546)
  • Product Description
    AUTOMATE 2550 AND 1250 ALIQUOTTER TIP PRESENT SENSOR
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.