Events

Recall of QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPC

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abacus ALS 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-2016-RN-00203-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00203-1
  • 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
    Investigations into complaints received have shown that in rare cases, the tests mentioned may give either falsely low crp resultsor the measurement flow is interrupted by the error message “faulty reagent addition”. falsely low crp results, in general, may providemisleading information for the diagnosis, therapy and monitoring of inflammatory disorders.The reported issue in a worst case scenario may cause a delay in starting the antibiotic treatment.
  • Action
    The sponsor is advising users to immediately quarantine and discontinue use of kits from the affected lots. This action has been closed out on 08 Jun 2017.

Device

QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPC
  • Model / Serial
    QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPCatalogue Number: 146521Production Lot: HX78Expiry Date: 24/11/2016QuikRead go wrCRP+HbCatalogue Number: 146255Production Lot: HX85Expiry Date: 31/01/2017ARTG Number: 206301
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd