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-00817-1
  • 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-00817-1
  • 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
    The manufacturer merck-millipore has advised seqirus of an issue with anti-m monoclonal blood grouping reagents producing weak or negative testing results when testing m+ red blood cells in line with the method described in the instructions for use (ifu). seqirus sources these reagents as raw material items, which are then subject to acceptance testing and labelling / packaging and then distributed as seqirus epiclone anti-m. as part of batch release these materials passed all potency and specificity requirements, and there have not been any product technical complaints or market feedback of testing issues regarding these products.
  • Action
    Seqirus is advising users to quarantine all affected stock from inventory. Seqirus will arrange collection of affected stock from customers.

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: 00980501Pack Size: 1 unit per packLot Numbers: 009817001, 009817101 (exp 10/11/17), 009817201 (exp 11/11/17), 009817301, 009817401 (exp 09/12/19) and 009817501 (exp 05/12/19)ARTG: 225013
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd