Events

Recall of UNICEL DXH SLIDEMAKER STAINER

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
    107595
  • Event Risk Class
    III
  • Event Initiated Date
    2012-10-04
  • 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
    The dxh sms with software version 1.5.1.0 will not read codabar labels at the primary barcode reader when the aim-16 checksum digit calculation is used with any leading and trailing characters that are not both "a" (e.G. a12345b). the codabar barcode symbology uses a single leading and trailing character as start and stop indicators with characters such as a b c or d. when the codabar symbology is used the labels can contain either matching or non-matching start and stop characters. if the character a is used for both the start and stop character (i.E.A12345a) the dxh sms will read the bar code label successfully. if any other start and stop characters are used the system will produce no read from the primary barcode reader.

Device

UNICEL DXH SLIDEMAKER STAINER
  • Model / Serial
    Model Catalog: 775222 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM PN 775222
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.