Events

SIMPLASTIN EXCEL - Lots: 161550, 161551, 161583, 161585, 161595, 161657, 161658, 161552, 161586, and 161596. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biomérieux Brasil S.A 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
    703
  • 날짜
    2003-04-07
  • 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
    Check if there are any batches in your stock. If any, please contact BIOMÉRIEUX BRASIL S / A, by telephone 21 2444.1483 - Technical Assistance to Reagents, in order to make the return and consequently the replacement of the same. The UTVIG - Technovigilance Unit is monitoring the entire collection, return and replacement process until it closes. According to the company's statement, the termination of this payment is scheduled until August 26, 2003.
  • 원인
    Prolonged results in coagulation times. there is variation of the measured levels of vacuum remaining in the lyophilized vials. this vacuum failure was identified as the cause of the randomly altered clotting times in those batches. according to this information, the presence of atmospheric air together with an active principle would be the cause of the poor performance observed in certain batches.
  • 조치
    The company informs that a number of Corrective Actions have been implemented for both the Simplastin Excel S product lines and Simplastin Excel. These are: Vacuum control, bottle to bottle, more stringent, improvement of the bottle closure system in the production process and revision of the technical procedure sheets: In the instructions for use a check of the reconstitution of the freeze-dried tablets by the customer, as well as performing a double quality control test before using the vial for testing. Collection of products manufactured in the period from February 2000 to November 2002.

Device

SIMPLASTIN EXCEL - Lots: 161550, 161551, 161583, 161585, 161595, 161657, 161658, 161552, 161586, ...

Manufacturer

Biomérieux Brasil S.A
  • Source
    ANVSANVISA