Events

CHEMICAL SYSTEM VITROS 5,1 FUSION, Registration no. 80145900827, lots: See Annex 1 - Distribution list. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc. 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
    1573
  • 날짜
    2015-05-04
  • 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 company informs that if this anomaly occurs, it is possible that the VITROS® 5,1 FS System processes samples with a cartridge other than the intended cartridge, leading to potential erroneous patient results.
  • 원인
    Ortho-clinical diagnostics, inc. (ocd) has confirmed two cases in which the vitros® microslide cartridge has not been correctly identified. both cases occurred when an operator accessed slide supply 1 (ss1) before the green indicator light came on and then continued loading a dry reaction cartridge into slide supply 2. in both cases, the cartridge loaded in slide supply 2 was not correctly identified.
  • 조치
    The solution to this anomaly will appear in the next version of software currently under development. We'll issue a follow-up notification as soon as the software is available. In the meantime, if an operator inadvertently accesses a Slide Supply loading port before the green indicator light comes on and the system generates a TAS-70E or TAS-20E condition code (SLIDE SUPPLY 1 is OPEN or the SLIDE PORT SUPPLY 2 is OPEN), the operator must open and close the two Slide Supply ports (Slide Supply No. 1 and 2), remove or load cartridges, and initialize the system. This will cause the system software to scan all slots on the two Slide Supplies to correctly identify the contents.

Device

CHEMICAL SYSTEM VITROS 5,1 FUSION, Registration no. 80145900827, lots: See Annex 1 - Distribution...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc.