Events

NHL, Ammonia - Registry 10287410128; NH3L - Registration 10287410768; GLDH-Glutamate Dehydrogenase - Registration 10287410752; CKMBL CK MB C111 Registration - 10287410673; CKMBL, Creatinine Kinase-MB - Registration 10287410530; CK-MB - Registration 10287410214; ASTLP, Aspartate aminotransferases acc. IFCC with pyroxidal phosphate activation - Record 10287410571; ASTL, Aspartate Aminotransferase acc. IFCC without pyroxidal phosphate activation - Record 10287410316; AST (ASAT / GOT) IFCC - Registration 10287410203; AST (ASAT / GOT) IFCC (SYS) - Registration 10287410258; ALTL, Alanine Aminotransferase acc. IFCC without phosphate activation - Record 10287410315; ALT (ALAT / GPT) IFCC (SYS) - Registration 10287410265; ALT (ALAT / GPT) IFCC - Registration 10287410184 - Lots and presentations - Annex I 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
    1633
  • 날짜
    2015-07-02
  • 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
    Sulfasalazine and Sulfapiridine may lead to potentially poor / high ALT, AST, CK-MB, GLDH, and NH3 testing in NAD (H) or NADP (H) ) in the reaction, which may lead to a delay in the decision of the medical evaluation.
  • 원인
    Roche diagnostics gmbh, a legal manufacturer of the products involved in this alert, made changes to the session of interfering with the use of nad (h) or nadp (h) tests (alt, ast, ck-mb, gldh and nh3), warning of possible drug interference of sulfasalazine and sulfapyridine. these changes were made in 2014.
  • 조치
    At therapeutic concentrations, Sulfasalazine and Sulfapiridine may lead to potentially inadequate low / high ALT, AST, CK-MB, GLDH and NH3 tests in NAD (H) or NADP ( H) in the reaction; The abovementioned test results may be inadequately low / high when the blood sample is collected in the presence of Sulfasalazine and Sulfapyridine in the patient's blood. • Physicians should be advised that patients currently receiving Sulfasalazine and Sulfapiridine may receive possible false results of ALT, AST, CK-MB, GLDH, and NH3. Further information - Annex II Letter to the Client and Annex III List of Customers

Device

NHL, Ammonia - Registry 10287410128; NH3L - Registration 10287410768; GLDH-Glutamate Dehydrogenas...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH