Events

Recall of DiaClon ABO/D+ Reverse Grouping for Patients. 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-2018-RN-00321-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00321-1
  • 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 have been made aware that a limited amount of id-cards diaclon abo/d + reverse grouping for patients, lot 50093 87 17, were packed in boxes stating a storage temperature range of 2-8°c on the outer carton instead of 18-25°c for this product.The product label shows the correct storage conditions for this product. this issue has no impact on product used prior to may 1 2018.
  • Action
    Bio-Rad is advising users to inspect their inventory to confirm that the affected lot has been stored between 18-25°C and not 2-8°C. If for any reason the product is stored at 2-8°C, please discard product after 1st May 2018.

Device

DiaClon ABO/D+ Reverse Grouping for Patients. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    DiaClon ABO/D+ Reverse Grouping for Patients. An in vitro diagnostic medical device (IVD).Catalogue Number: 001267Displayed Lot Number: 50093 87 17SAP Lot Number: 2201808717Expiry Date: 31/01/2019ARTG Number: 212527
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd