Events

COBAS P 512 PRE-ANALYTICAL SYSTEM Technical name: Instrument for the preparation and processing of samples - preanalytical phase ANVISA registration number: 10287411162 Hazard class: I Serial numbers affected: 64002616; 64002716; 64002816; 64002916; 64003016; 64003116; 64007017 (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
    2312
  • 날짜
    2017-06-12
  • 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
    Verify that the Rotate Status Detection feature is used in accordance with the updated Operator's Manual. (update described in the field action notification letter).
  • 원인
    Roche diagnostics gmbh, manufacturer of the product, initiated this field action as it identified opportunities for improvements in the detection of rotation and re-labeling of the cobas p 512 pre-analytical system upon receipt of complaints from two customers reporting that non-standard samples - centrifuges were incorrectly identified as "centrifuged" by detecting the rotation state in the cobas p 512 (64x) preanalytic system. in investigating such complaints, roche diagnostica has identified that all documentation related to the state of rotation detection needs to be updated to reflect the correct use intended.
  • 조치
    Field Action Code SBN-CPS-2017-010 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

COBAS P 512 PRE-ANALYTICAL SYSTEM Technical name: Instrument for the preparation and processing o...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH