Events

ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abacus ALS Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-00222-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-02-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00222-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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).
  • 모델명 / 제조번호(시리얼번호)
    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