Events

Recall of Randox Lipase Reagents for use on RX instruments. 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 Randox 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-2018-RN-00239-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00239-1
  • 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
    Randox have identified that the reagent triglycerides can cause elevated lipase results when the lipase reagent is run after triglycerides within the same run. this can affect a qc or patient sample test result. randox have now released further steps for contamination avoidance with the lipase assay on rx instruments. users should refer to the instrument testing order specifically arranging chemistries so that lipase and triglycerides are the last two chemistries in the test running order.In the event of an extremely elevated lipase result, cuvette maintenance steps should be performed as recommended for each rx system. the sample should then be re-tested running the lipase assay in isolation.
  • Action
    Randox is advising customers and distributors to amend their test running order and update the RX analyser operator manual with the revised information. Updated IFU's will be provided to users. In the event of an extremely elevated Lipase result, cuvette maintenance steps should be performed as recommended for each RX system. The sample should then be re-tested running the Lipase assay in isolation.

Device

Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)Catalogue Numbers: LI7979, LI8050ARTG Number: 199615(Randox Australia - Clinical chemistry enzyme IVDs)
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA