Events

Recall of Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identification of Shigella dysenteriae). 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 Oxoid Australia 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-2014-RN-00868-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00868-1
  • 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
    An internal technical investigation by the manufacturer has identified that the listed lot numbers of shigella dysenteriae polyvalent (1-10) agglutinating serum may react with negative isolates, resulting in false positive results.
  • Action
    Oxoid Australia Pty Ltd is recalling the affected batches of product. End users are requested to inspect their stocks and remove from further use all units from the above lot numbers. The requirement for review of patient results should be determined by the laboratory director. This action has been closed-out on 03/06/2016.

Device

Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identifica...
  • Model / Serial
    Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identification of Shigella dysenteriae). An in vitro diagnostic medical device (IVD)Product Code: R30163701Carton Lot Number: 1111470Bottle Lot Number: 1130078Carton Lot Number: 1236726Bottle Lot Number: 1297592
  • Manufacturer
    Oxoid Australia Pty Ltd

Manufacturer

Oxoid Australia Pty Ltd