Events

Recall of ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD). LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, and DiaClon Type + Screen

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bio-Rad Laboratories 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-00318-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00318-1
  • 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
    Bio-rad laboratories have been able to confirm an increased level of antibody of undetermined specificity (aus) when using some reagents of the id-system intended for irregular antibody screening and identification.
  • Action
    BioRad is advising that the capacity of impacted lots of ID-Cards to detect and identify clinically significant antibodies is not affected by this issue. For that reason users may continue to use these products for their intended purpose. In the event users experience an AUS level impacting the ability to render final results, users should consider using an alternative method such as the tube method to verify results.

Device

ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro d...
  • Model / Serial
    ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD). LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, and DiaClon Type + ScreenProduct ID Numbers: 50531, 50540, 50571, 50581,50682Multiple Catalogue and Lot NumbersARTG Number: 212527(Bio-Rad Laboratories - Multiple blood grouping and typing IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd