Events

ABBOTT REALTIME HIV-1 AMPLIFICATION REAGENT KIT, registry: 80146501493, Class of Risk: IV; serial number / lot: 462605. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Abbott Molecular Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1766
  • 날짜
    2015-11-24
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    Although this problem may cause more problems than the expected error codes, you are not expected to display incorrect results. If an error code is generated, the user may lose the sample or correct test operation (if a control has been affected). This could cause a delay in the result. //// The Abbott RealTime HIV-1 AMPLIFICATION REAGENT KIT assay uses internal controls and amplification techniques. Additional data will be collected for these two tests. As such, an action is being taken to update this risk assessment upon completion of this additional data collection. To date there has been a higher frequency than the expected complaint associated with the HIVTI-qualitative RealTime and HCV GTII assays.
  • 원인
    According to the registry holder, it was identified that the batch of the abbott realtime hiv-1 amplification reagent kit is producing a higher-than-expected error code index or a change in the expected threshold cycle-ct. the research concluded that these problems are due to an oligonucleotide (oligo) reagent, which reduces efficiency and causes a change in ct value.
  • 조치
    The registrant recommends that if you observe the error codes listed in Appendix A when using the Abbott RealTime HIV-1 Amplification reagent kit, lot 462605, contact Technical Support at 0800 70-20711 or your representative Abbott Molecular site. Customers can be considered from 03 situations: those that have the affected lot, but did not obtain an error during processing. In this case, the customer can continue to use the kit without problems. /// Others that even though they have not faced problems (processing errors), may not feel comfortable using the lot. If customers contact the Call Center, they will register the product exchange request./// For customers who experience the problem described in Field Action and contact the Call Center, register the ticket in the system and automatically be raised for investigation, so that the manufacturer to identify the situation. The customer may choose to receive credit / exchange only the quantity of samples that presented problems / losses, or all the amount of kits that still have from that lot. . code FA-AM-NOV2015-208.

Device

ABBOTT REALTIME HIV-1 AMPLIFICATION REAGENT KIT, registry: 80146501493, Class of Risk: IV; serial...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Abbott Molecular Inc.
  • 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
    ANVSANVISA