Events

Name of the product: cobas® connection modules (CCM) - OUTPUT UNIT, accessory of the products under registration 10287411162 (cobas p512 and p612) Technical name: SAMPLE PROCESSOR ACCESSORY FOR HEALTH DIAGNOSIS ANVISA registration number: 10287411162 Hazard class: I Numbers Affected series: 20496176 204C5683 204C5684 204C5691 204C5692 204C5693 204C5694 204C5695 204C5700 (Roche stock) 204C5701 (Roche stock) 204C5702 (Roche stock) 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
    2291
  • 날짜
    2017-05-17
  • 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
    If you identify that your unit is affected by rack vibration and samples are required for further processing, the unit should not be used until the Roche Diagnostica Brazil Field Service Representative performs the adjustment procedure. Potentially affected sample tubes should be disposed of in accordance with local regulations. An adjustment procedure that solves this problem is now available. All affected systems will be adjusted by a Field Service Representative from Roche Diagnostics Brazil.
  • 원인
    Roche diagnostics gmbh, a legal offshore manufacturer, has received a 5-position rack-related complaint on the output unit unit that was not being gently pushed into the tray and may cause rack vibration during sample transport, leading to possible spillage of the sample tube material.
  • 조치
    Field Action Code SBN-CPS-2017-008 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Name of the product: cobas® connection modules (CCM) - OUTPUT UNIT, accessory of the products und...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH