Events

Recall of UNICEL DXC 600

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
    53044
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-17
  • 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 failure of the unicel dxc ise tubing (lines 11 25 and 26) for ise reference reagent. the failure occurs due to the interaction between a new tubing plasticizer and the ise reference reagent. the supplier's change in plasticizer was a result of a move to a phthalate-free tubing material based on new environmental regulations. as a result a slowforming non-microbial white material may appear inside the tubing. observed symptoms of the presence of the white material can include suppressed ion specific electrode (ise) quality control and patient results ise calibration failures and detached tubing lines 25 or 26 due to obstruction of flow. current investigation suggests it is highly unlikely that incorrect results will be generated.

Device

UNICEL DXC 600
  • Model / Serial
    Model Catalog: 4764 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4773 (Lot serial: 3048); Model Catalog: 4773 (Lot serial: 4282); Model Catalog: 4767 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4771 (Lot serial: 4036); Model Catalog: 4768 (Lot serial: 4143); Model Catalog: 4768 (Lot serial: 2788); Model Catalog: 4768 (Lot serial: 3563)
  • Product Description
    UniCel DxC 600 SYNCHRON Clinical Systems
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.