Events

Recall of UNICEL DXH 800 COULTER CELLULAR ANALYSIS 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
    69302
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-24
  • 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
    Sample analysis cycle time for specimen with high white blood cell (wbc) counts (approximately 45.0 x 103 /ul or higher) is approximately two (2) minutes longer than expected for the dxh analytical systems with the software revisions unicel dxh 800 coulter cellular analysis system software revision 2.0.2.1 and unicel dxh 600 coulter cellular analysis system software revision 1.0. the original total sample analysis cycle time (analysis and cleaning cycle) was approximately two and a half (2 1/2) minutes while the current cycle time is approximately five and a half (5 1/2) minutes. test results are not affected by this issue.

Device

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Model / Serial
    Model Catalog: 629029 (Lot serial: ALL); Model Catalog: B23858 (Lot serial: ALL)
  • Product Description
    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.