Events

Hemoglobin A1c (HbA1c) ReagentAn in vitro medical device. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abbott Australasia Pty Ltd Diagnostic Division 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-01539-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01539-1
  • 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
    Abbott has identified fetal hemoglobin (hbf) interference occurs at a level lower than what is stated in the hba1c reagent package insert. the package insert states that the hba1c assay is susceptible to interference effects from hbf at > 20%, while the most current data shows interference from hbf at > 5%. hba1c results are invalid for patients with abnormal amounts of hbf, including those with known hereditary persistence of fetal hemoglobin. in healthy adults, approximately 95% of hb is hba, with small amounts (<3.5%) of hba2 and hbf present.
  • 조치
    Abbott is advising customers to be aware that falsely depressed results could occur when the HbF variant level in patient samples in >5%. Additional updates to the HbA1c reagent package insert will be provided to users once available.

Device

Hemoglobin A1c (HbA1c) ReagentAn in vitro medical device.

Manufacturer

Abbott Australasia Pty Ltd Diagnostic Division
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA