MEDISENSE OPTIUM GLUCOSE STRIP TRUE MEASURE - Test Strips 10 Units Registration ANVISA nº10055311118 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATORIOS DO BRASIL LTDA 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
    813
  • 날짜
    2005-08-10
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    This exchange, which signifies a disagreement with the date printed in the original box, occurred only in the first stage of adequacy, therefore both boxes with the correct validity and the incorrect validity were distributed on the market. The company Abbott Laboratories of Brazil, Diabetes Care Division, further clarifies that the Test Strips 10 Medisense Optium units are packaged individually, and in each strip there is printed information of the lot and the expiration date, which becomes visible at the correct date each use of the Test Strips. You still understand that this product will hardly be used after the correct expiration date (28/0212006), as it contains only 10 units. ANVISA will be accompanying the actions that will be carried out by the company.
  • 원인
    The product medisense optium - test strips with 10 units, lot 10422 with validity to 02/28/06, at the moment of adaptation, that is, in the labeling (which is done only to include the legal words - dealer's data in brazil, registration number, etc ...) there was an exchange of the product's expiration date. correct validity date: 02/28/06 - printed in the original box incorrect validity date: 06/28/06 - on the portuguese label.
  • 조치
    The company issued a letter to its customers and is awaiting contact to know the impact of this occurrence on the stock and to meet the need to correct this operational failure. The company makes itself available for any clarification necessary through the Customer Service Center 0800 7030128 of Monday on Friday from 08:00 to 18:00 hours.

Manufacturer