Events

Recall of LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

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
    RC-2013-RN-01284-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01284-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Update: beckman coulter's investigation has shown that the lh cleaner and coulter clenz was the main contributor to the optical degradation issue.Complaints related to optical degradation have increased on the lh 750 and lh 780 haematology systems. customers have reported an increase in ls offset error messages during startup, background, control and/or patient analysis.The optical degradation may potentially cause a delay in reporting results for nucleated red blood cells, white blood cell differential and/or reticulocytes.Cbc panel results are available for reporting and are not affected by this issue.
  • Action
    Update: Beckman Coulter is requesting their customers to discard the affected lot of LH Cleaner. Laboratories can discontinue the additional Clear Flow Cell and Extended Cleaning actions. Beckman Coulter is recommending users perform a Clear Flow Cell and Extended Cleaning and perform a routine shutdown at least daily. Beckman Coulter is investigating this issue further in order to provide a permanent fix.

Device

LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)LH 750 Haematology SystemPart Numbers 6605632 and A85570LH 780 Haematology System Part Numbers 723585 and A90728
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd