Events

CHEMICAL SYSTEM VITROS 4600 (Reg 80145900827) / CHEMICAL SYSTEM VITROS 5,1 FUSION (Reg 80145900827). Hazard Class: I. Products Affected: All VITROS® 4600 Diagnostic Systems with softaware version 3.2 and earlier and all VITROS® 5.1 Fusion Diagnostic Systems with software version 2.8 and earlier. List of affected SNs distributed in Brazil are in Annex I of this notification. 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
    1772
  • 날짜
    2015-12-18
  • 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
    Considering the reduced likelihood that the anomaly will occur (<1 in 14 million), it is possible for the VITROS® 4600 and 5.1 FS Systems to process samples outside the appropriate temperature range where results will not be indicated with a result code of "IT" (incubator temperature).
  • 원인
    Ortho clinical diagnostics (ortho) has recently identified that under very specific conditions the temperature in the microwell subsystem (included in other vitros® systems) may potentially be out of range and the system does not properly alert the operator. although it does not include a microwell subsystem, the vitros® 4600 and 5.1 fs systems use the same software as the other vitros® systems. ortho has estimated that there is a 1 in 14 million lower incidence possibility that this anomaly might occur in the microslide or microtip subsystems included in the vitros® 5,1 fs systems, based on e-connectivity data.
  • 조치
    Recommendations to users and patients: Because of the reduced likelihood of this anomaly occurring, Ortho is not requiring the temperature of its system to be monitored. However, the customer may choose to check that his system is within the appropriate temperature range. Field Action Code: 15000167

Device

CHEMICAL SYSTEM VITROS 4600 (Reg 80145900827) / CHEMICAL SYSTEM VITROS 5,1 FUSION (Reg 8014590082...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; ORTHO CLINICAL DIAGNOSTICS, INC