Events

Cobas® HIV-1 and HBV Technical Name: ANVISA Registration Number: Hazard Class: IV Model Affected: Registries: 10287411153 and 10287411154 Serial Numbers Affected: 1) cobas® HIV-1 Test (6979599190) Lot W11636 2 ) cobas® HBV Test (6979564190) Lot W14007 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH 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
    2224
  • 날짜
    2017-02-22
  • 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
    The INCQS has been duly informed on this issue in case there is a need for action. There are no users / patients affected by this issue. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • 원인
    Roche diagnostica brasil has received from its overseas manufacturer (roche diagnostics gmbh) a statement regarding the results of the cobas® hiv-1 and cobas® hbv tests used in the cobas 4800 system and, therefore, shares the information only for information, since brazil did not import these batches for use in clinical laboratories. the tests were all used for analysis and validation in incqs (national institute of health quality control) and there is no risk of release of results for patients. field action title: potential false negative result with the cobas® hiv-1 and cobas® hbv tests for use in the cobas 4800 system.
  • 조치
    Field Action Code SBN-RMD-2016-024 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make information.

Device

Cobas® HIV-1 and HBV Technical Name: ANVISA Registration Number: Hazard Class: IV Model Affected:...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH