Events

Recall of Various Microgenics Applications Sheets. 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-2017-RN-00871-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00871-1
  • 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
    It has been determined that application sheets provided by the manufacturer microgenics for expanded use of some assays are inadequate. specifically, the appropriate validation data for the expanded use of these assays, as indicated in the instructions for use (ifu) when not used on manufacturer approved analysers, is inadequate. in addition, microgenics did not clearly state in these application sheets that the parameters provided are only to be used as starting points and that each assay setting needs to be validated individually by the user.Thus the information given on the specific application sheets for use with non-microgenics approved analysers may be ineffective. it is possible that assays not validated for use with other instrument platforms could potentially lead to erroneously low or high test results.
  • Action
    Beckman Coulter is requesting Customers: 1. Immediately check if they are using any of the affected Application Sheets on the platforms as listed in the letter supplied; and 2. Discontinue use of the affected Application Sheets. Review their internal assay validations to determine if the current instrument settings using these Assays require additional action within the clinical laboratory setting. If customers have performed a compliant self-validation of a particular Assay on a specific instrument in accordance with applicable laboratory certifications or requirements, they may be able to continue to use that Assay on the corresponding instrument. Consult a qualified healthcare professional as appropriate. If they have performed a compliant self-validation, note that on the supplied Vigilance Response Form.

Device

Various Microgenics Applications Sheets. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Various Microgenics Applications Sheets. An in vitro diagnostic medical device (IVD)Multiple Assays / Instrument PlatformsAll LotsARTG Numbers 274335 and 275701
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd