Events

Recall of UNICEL DXC 600I SYNCHRON ACCESS CLINICAL ANALYZER

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
    97031
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-11
  • 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 confirmed that the dxc 600i system can generate a "cta cable down - lost connection" error (error code: 0x139f0074) that requires rebooting the cta. the "cta cable down - lost connection" error will not occur on dxc systems that do not use closed tube sampling (cts) tracking. this event will only occur on dxc systems that have cts tracking enabled. this issue can affect dxc 600i systems that have cts tracking enabled when any of the following occur: - sample id's are cleared on any networked dxc system - a networked dxc 600i is rebooted - any dxc system networked to a dxc 600i is rebooted.

Device

UNICEL DXC 600I SYNCHRON ACCESS CLINICAL ANALYZER
  • Model / Serial
    Model Catalog: 4767 (Lot serial: > 10 numbers contact mfg); Model Catalog: A25638 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    UNICEL DXC 600I SYSTEM CLOSED TUBE ALIQUOTTER (CTA) UNIT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.