Events

Recall of DXH 500

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
    144731
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-07
  • 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 determined that if the bleach cycle is interrupted or aborted the dxh 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. should a bleach cycle get interrupted the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected. patient results may be impacted due to residual bleach in the diluter when a sample is processed immediately after a bleach cycle is interrupted.

Device

DXH 500
  • Model / Serial
    Model Catalog: B40601 (Lot serial: AZ120651); Model Catalog: B40601 (Lot serial: AZ120636); Model Catalog: B40601 (Lot serial: BA070451); Model Catalog: B40601 (Lot serial: BA060399); Model Catalog: B40601 (Lot serial: AZ120657); Model Catalog: B40601 (Lot serial: AZ120656); Model Catalog: B40601 (Lot serial: AZ120655); Model Catalog: B40601 (Lot serial: AZ110582); Model Catalog: B40601 (Lot serial: BA070450); Model Catalog: B40601 (Lot serial: AZ060306); Model Catalog: B40601 (Lot serial: 1.0.2 and 1.1); Model Catalog: B40601 (Lot serial: AZ030171); Model Catalog: B40601 (Lot serial: BA060398)
  • Product Description
    DXH 500 OPEN-VIAL HEMATOLOGY SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.