Events

ALKALINE WASH, registration: 80146501155, hazard class: I, serial / lot number: 49059UN14. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Abbott laboratories Diagnostics Division. 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
    1583
  • 날짜
    2015-05-13
  • 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
    According to the company the solution contained in this product presents a potential chemical hazard because the alkaline solution is corrosive and the operator may be exposed when the bottle is leaking. According to the Material Safety Data Sheet, severe burns to the skin and mucous membranes may occur.
  • 원인
    Product or material with loose lids causing leakage during transport. the alkaline solution is corrosive and worker exposure may occur.
  • 조치
    The record holder will collect and destroy the product. The company asks customers to verify that Alkaline Wash, LN 9D31-20, lot 49059UN14 is in use or in stock. If yes, perform, using appropriate personal protective equipment (PPE), visual inspection in your inventory. If any signs of leakage or loose lids are observed, discontinue use immediately and segregate any remaining stock from these kits in accordance with your institution's policy and procedures for later recall. You DO NOT observe any signs of leakage or loose covers, you may continue to use the product following the precautions in the ARCHITECT System Operations Manual and Safety Data Sheet. For more information, see the attached Letter to the Client.

Device

ALKALINE WASH, registration: 80146501155, hazard class: I, serial / lot number: 49059UN14.

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Abbott laboratories Diagnostics 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
    ANVSANVISA