Events

Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abbott Australasia Pty Ltd Molecular 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-01057-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01057-1
  • 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 molecular has identified that a specific lot of abbott realtime hiv-1 assay may exhibit a higher than expected rate of error codes. for plasma samples, this has the potential to exhibit false “not detected” results for hiv samples less than 120 copies/ml when using 0.6 ml assay application. for dried blood spot (dbs) samples when using a 1-spot protocol associated with the realtime hiv-1 package insert 51-608282, these are performing in accordance with the detection rate within the realtime hiv-1 package insert for dbs sample types.
  • 조치
    Abbot is requesting users: 1. Review the supplied Abbott Molecular letter carefully and follow the instructions; 2. Complete and return the supplied Customer Reply Form; 3. Contact Abbott Customer Service for assistance if needed. If customers have forwarded the affected product to other laboratories, inform them of this Product Recall and provide to them a copy of the customer letter; and 4. Retain this letter for your laboratory records.

Device

Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD)List Number: 02G31-010Lot Number: 475025ARTG Number: 217841
  • Manufacturer
    Abbott Australasia Pty Ltd Molecular Division

Manufacturer

Abbott Australasia Pty Ltd Molecular 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