Events

Recall of UNICEL DXC 880I 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
    27982
  • Event Risk Class
    III
  • Event Initiated Date
    2013-03-20
  • 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
    1. when archiving to a usb flash drive if the calibrator name contains the forward slash "/" character the calibration report will not be archived for the affected calibrators. there is no warning or message to tell the customer that the calibration report has not been archived. calibrator archive reports for these calibrations are not created and the calibration information is not available to download to the usb flash drive. calibrators affected: iron/ibct lx/dxc apo (lx/dxc apo cal on the cal disk) lx/dxc ma lx/dxc pab. 2. when upgrading from one version of 5.0 to another the calibration files that are older than the most recent five calibrations but have not been archived to the usb flash drive are not transitioned to the new version of software. as a result these calibration files are not available to download to the usb flash drive after the upgrade. this issue also affects a "parallel upgrade" in which the same version of 5.0 software is reinstalled on the system.

Device

UNICEL DXC 880I SYNCHRON ACCESS CLINICAL ANALYZER
  • Model / Serial
    Model Catalog: A59102 (Lot serial: 4143); Model Catalog: 4768 (Lot serial: 4143); Model Catalog: A59102 (Lot serial: 3563); Model Catalog: 4768 (Lot serial: 3563); Model Catalog: A59102 (Lot serial: 2788); Model Catalog: 4768 (Lot serial: 2788); Model Catalog: 4764 (Lot serial: > 10 numbers contact mfg); Model Catalog: A11816 (Lot serial: > 10 numbers contact mfg); Model Catalog: A64935 (Lot serial: 4282); Model Catalog: 4773 (Lot serial: 4282); Model Catalog: 4767 (Lot serial: > 10 numbers contact mfg); Model Catalog: A10405 (Lot serial: > 10 numbers contact mfg); Model Catalog: A27318 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    UNICEL DXC 880I SYNCHRON ACCESS CLINICAL ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.