Events

Recall of ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abacus ALS 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-2016-RN-00014-2
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00014-2
  • 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 ranges for mean concentration of igg/igg4 stated on the vial label of the quality control sample are incorrect. the new measuring ranges for immunocap specific igg/igg4 i1 control h, all lots when used in combination with immunocap i1, lot 389b7 and 389b8 are:igg4: 12 – 25 mg/ligg: 24 - 47 mg/lthe problem can be detected by the operator since the quality control samples will fail.
  • Action
    The sponsor is advising users to use the following new measuring ranges for ImmunoCAP Specific IgG/IgG4 i1 Control H: IgG4: 12 – 25 mg/l IgG: 24 - 47 mg/l Patient results are not affected. No action needs to be taken in regards to past or current patient results for ImmunoCAP Allergen i1, Honey bee venom.

Device

ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)
  • Model / Serial
    ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)Part Number: 10-9475-01Lot Numbers: All lot numbers when used in combination with ImmunoCAP Allergen i1Honey bee venom art. No 14-4143-01, lot numbers 389B7 and 389B8ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd