Events

Recall of SYNCHRON Systems Lactate (LACT), 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-00364-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00364-1
  • 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
    Beckman coulter has received customer reports of suppressed lact results for samples containing lact concentration of 6.5 mmol/l or greater, when using the affected lot number. internal testing confirmed that the issue for samples containing lact concentrations between 9.2 and 11.0 mmol/l. although these results are within the analytical range of 0.3 - 11.0 mmol/l, the results are suppressed and the system identifies the error condition rxn rate hl.
  • Action
    Beckman Coulter is asking users to cease using the affected lot and is offering a replacement.

Device

SYNCHRON Systems Lactate (LACT), An in vitro diagnostic medical device (IVD)
  • Model / Serial
    SYNCHRON Systems Lactate (LACT), An in vitro diagnostic medical device (IVD)Reference: A95550Lot Number: M206209Expiry: 2013-04-30
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd