Events

Recall of SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Immuno 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-01176-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-11-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01176-1
  • 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
    Fertipro has informed that some customers have reported reduced motility in certain semen samples when using the updated spermmar iga test (brown beads). this reduced motility may result in a lower proportion of free moving sperm and affect the interpretation of the results.
  • Action
    Customers are instructed to stop using and destroy the affected batches. Fertipro is currently working on optimising the buffer of the reagent to avoid this reduction in motility. The optimised reagent will be included from batch FP14A11 onwards. Users are advised that the need for a look back at previously reported results be discussed with their clinical/laboratory director. This action has been closed-out on 01/03/2016.

Device

SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA)
  • Model / Serial
    SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA) BatchNumber: FP14A09, FP14A10An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA