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
    146196
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-14
  • 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 inc. has identified four issues with the unicel dxh 800 coulter cellular analysis system: 1.Specimen tubes may fall out of a type a cassette when the analyzer inverts the cassette in the mixing station or when an operator manually inverts a cassette. 2.The dxh 800 may fail to meet the carryover specification for the wbc differential (diff) when the wbc is greater than 70 x 103 cells/ul (70 x 109 cells/l). 3.The dxh 800 may fail to meet the carryover specification for nrbc% when the wbc is greater than 50 x 103 cells/ul (50 x 109 cells/l). 4.The handheld barcode scanner does not read barcode labels using nw 7 symbology.

Device

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

Manufacturer

BECKMAN COULTER CANADA L.P.