Events

Recall of ID-Papain Assay. 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-2016-RN-00492-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00492-1
  • 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
    Following customer complaints, bio-rad has been able to confirm that the affected lots show a decrease in enzymatic activity, leading to false negative or false positive results. bio-rad is recalling the lots identified. this recall is being conducted as a precautionary measure.A risk assessment has been carried out and revealed that difficulty in interpretation of the results involving identification, auto-control and cross-matching in the enzyme technique may be experienced which may result in a delay in transfusion.
  • Action
    Bio-Rad is advising customers to destroy remaining units of the affected lots, and is recommending using ID-Diluent as an alternative. This action has been closed-out on 03/02/2017.

Device

ID-Papain Assay. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ID-Papain Assay. An in vitro diagnostic medical device (IVD)Catalogue Number: 005510Lot Numbers: 06311.53.1 (Expiry date 25/04/2016)06311.54.1 (Expiry date 09/05/2016)06311.55.1 (Expiry date 23/05/2016)ARTG Number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd