Events

Recall of ImmunoCAP Allergen fx20, Food. 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-2017-RN-00222-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00222-1
  • 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
    Immunocap allergen fx20, food contains a mix of f4 (wheat), f5 (rye), f6 (barley), f9 (rice). due to a production non-conformity, certain lots of immunocap allergen fx20, food, may contain traces of oat (f7) allergen. this could cause false positive test results with regard to sensitisation to fx20 allergens for samples that are positive for oat allergen and negative for wheat, rye, barley, and rice allergens. however, this is an unlikely event because of the extensive cross-reactivity between the different cereal allergens and the low probability of monosensitisation to oat allergen in patients. therefore, it is unlikely that presence of oat allergen in immunocap allergen fx20 should result in incorrect test results for patient samples.
  • Action
    Abacus ALS is advising users of the possibility of false positives with the assay due to the presence of oat allergen. ImmunoCAP whole allergens f4, f5, f6 and f9 can be used as an alternative for testing of patient samples.

Device

ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).Lot Numbers: AAS0D (exp 31 Mar 2012)AAS0E (exp 31 Mar 2013)AAS0F (exp 31 May 2014)AAS0G (exp 30 Nov 2014)AAS0H (exp 31 Jan 2015)AASG1 (exp 31 Jul 2016)AASG2 (exp 30 Jun 2016)AASG3 (exp 30 Jun 2018)ARTG Number:186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd