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
    71085
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-28
  • 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
    Beckman coulter has identified an incompatibility between no foam dxc reagent (ref b64130) and the dxc hydropneumatic parts associated with no foam delivery. dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. over time this incompatibility may lead to: breaks in no foam cap assembly (pn a84827) cracks in no foam waste collector (pn a60007/a64665) seepage outside no foam tubing (pn's a10027 a10028 and a67123). this incompatibility does not affect no foam's ability to perform its function and there is no impact to patient results. cracks in the waste collector may stop instrument operation due to vacuum error and potentially lead to biohazardous waste exposure. cracks in the no foam cap and seepage from the no foam tubing may lead to exposure to no foam.

Device

UNICEL DXC 600
  • Model / Serial
    Model Catalog: 4764 (Lot serial: ALL); Model Catalog: 4772 (Lot serial: ALL); Model Catalog: 4773 (Lot serial: ALL); Model Catalog: 4767 (Lot serial: ALL); Model Catalog: 4771 (Lot serial: ALL); Model Catalog: 4768 (Lot serial: ALL); Model Catalog: B64130 (Lot serial: ALL)
  • Product Description
    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEMS;UNICEL DXC 680I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS;UNICEL DXC 860I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS;UNICEL DXC 600I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS;UNICEL DXC 800 SYNCHRON CLINICAL S
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.