Events

Recall of Epiclone Anti-M Blood Grouping Reagent. 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 Seqirus 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-01361-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01361-1
  • 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
    Seqirus has received notification that epiclone anti m lot 009817601 is showing false positive m reactions with m negative control cells in cat (column agglutination technology) biovue cards. investigational testing by seqirus suggests that there is an incompatibility between anti-m lot 009817601 and the cat biovue cards.
  • Action
    Seqirus is advising customers to only use the product for phenotyping via the Tube method. Users should not continue use of the product with Column Agglutination Technology (CAT) Cards. Seqirus is advising laboratories to perform a review of previous positive reactions obtained where CAT Cards have been used with Epiclone Anti M Lot 00981760.

Device

Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)Product Item Number: 00980501Expiry: 11/06/2019Pack Size: 1 unit per packLot Number: 009817601ARTG: 225013 (Immunohaematology blood grouping
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd