Events

Recall of ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. 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 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-01496-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01496-1
  • 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
    For particular lot combinations of immunocap specific igg/igg4 i1 control h and immunocap allergen i1, honey bee venom, the ranges for mean concentrations of igg and igg4 stated on the vial label of the quality control sample are incorrect. the problem can be detected by the operator as the quality control samples will fail. the issue affects the immunocap specific igg/igg4 i1 control h samples only; patient results for i1 are not affected by the lot number of immunocap allergen i1, honey bee venom, used to generate the assay result. the correct measuring ranges for the quality control are being provided.
  • Action
    Abacus ALS is providing users with the correct measuring ranges for ImmunoCAP Specific IgG/IgG4 i1 Control H, vial lots with expiry date until July 2017 (C6XAX or older), when used in combination with ImmunoCAP i1, lots 389B7, 389B8, 389B9, 389BA & 389BB. The correct ranges are: IgG4: 12 – 25 mg/l and IgG: 24 - 47 mg/l. No action needs to be taken in regards to past or current patient results for ImmunoCAP Allergen i1, Honey bee venom. This action has been closed out on 15 June 2017.

Device

ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. A...
  • Model / Serial
    ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. An in vitro diagnostic medical device (IVD).ImmunoCAP Specific IgG/IgG4 i1 Control HArticle Number: 10-9475-01Vial Lots: with expiry date up to July 2017 (C6XAX or older)ImmunoCAP Allergen i1, Honey bee venomArticle Number: 10-4143-01Lot Numbers: 389B7, 389B8, 389B9, 389BA & 389BB ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd