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
    22724
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-21
  • 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 confirmed 5 issues on the unicel dxht 800 coulter cellular analysis system. issue 1: there is a possible dilution of sample if user requests a diluent dispense while specimens are being processed in cassette presentation resulting in erroneous results. issue 2: cbc: rbc and hct are improperly corrected and not flagged when there is a wbc pump error and the reported wbc > 140/ul. in body fluid (bf) panels: rbc is improperly corrected and not flagged when there is a wbc pump error. issue 3: there is a potential for erroneous retic results when the instrument user interface allows reflex processing of pre-diluted specimen in the retic test panel instead of limiting processing to cbc only. issue 4: there is the potential for body fluid results to be incorrectly interpreted by the laboratory information system. issue 5: sharp edges on the dxh800 reagent cabinet (floor stand) drawer slides may expose operators to physical injury while replacing reagents and waste containers.

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.