Events

Recall of COULTER LH 750 HEMATOLOGY ANALYZER

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
    44404
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-19
  • 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. identified the following issues with the above listed products: issue 1: after downloading interlaboratory quality assurance program (iqap) files to removable media the system prevents access to system setup screen and history logs. issue 2: the on-line help (ifu) instructions for lh 750 and lh 780 instruments do not provide the correct procedures to format a disk (cd) for saving or archiving data where those instruments are connected to small form factor (sff) computers.

Device

COULTER LH 750 HEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 6605632 (Lot serial: ALL); Model Catalog: 723585 (Lot serial: ALL); Model Catalog: 178833 (Lot serial: ALL)
  • Product Description
    COULTER LH 750 HEMATOLOGY ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.