Events

Homocysteine ​​Enzymatic Assay /// Registration 10287411008 /// Technical Name: Homocysteine ​​/// Risk Class: II - products of medium risk to the individual and / or low risk to public health, subject to registration /// Lots: 69781101 /; 69781401; 69780301 (SCHEDULE OF DISTRIBUTION IN ANNEX) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH; Unomedical 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
    1549
  • 날짜
    2015-04-10
  • 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
    Actions to be taken by the customer / user, according to the company: • Customers must stop using the affected product (affected batches), eliminating it locally and switching to subsequent batches of HCYS that are not affected: Batch Affected: 69780301 / 69781101/69781401 - Expiry date30 / 04/2015 - Using Subsequent Batches: 607116101/60716801/60717101 - Validity 1/31/2016
  • 원인
    The company reported that "customers complained of a 20% decrease in control levels when using non-roche controls (eg, thermofisher liqimmune) with the reagent homocysteine ​​from lot 697811 on cobas c 501 equipment. lot 604303, controls were within range. comparison of patient samples with reagent lot 697811 versus lot 604303 showed a deviation of up to 54%. plasma samples were used in edta. this negative deviation could result, in the worst case, in low homocysteine ​​results. however, it is unlikely that inaccurately low homocysteine ​​results could have caused an immediate adverse event, since homocysteine ​​has been shown to be an indicator of long-term cardiovascular risk (late cardiac events) rather than short-term events. ".
  • 조치
    Company communicated its customers by letter (LETTER IN ANNEX) Type of action: Notice to Customers and Distributors not to use affected lots (LETTER IN ANNEX) /// Code: SBN_RPD_2015_006

Device

Homocysteine ​​Enzymatic Assay /// Registration 10287411008 /// Technical Name: Homocysteine ​​//...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH; Unomedical