Events

Recall of ID-LISS/Coombs Cards. 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 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-2015-RN-00314-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00314-1
  • 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
    Unexpected reactions may rise in the 6th well of lot 50531.95.14 (exp. date 30/06/2016) product id: id-liss coombs cards reference 004017v (24 x 12 id-cards). investigations have identified that a high level of 'broken gel' during a certain time period during filling and only a very limited quantity of id-cards are affected by this phenomenon of unexpected reaction in the 6th well.
  • Action
    To limit unexpected reactions, customers are asked to stop using the affected boxes (number between 5-1156-288 and 5-1156-318) and to destroy the remaining stock locally. Replacement unaffected stock will be sent.

Device

ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)Ref: 004017VLot Number: 50531.95.14 (Exp 30.06.2016)Affected Box numbers: 5-1156-288 to 5-1156-318ARTG number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd