Events

Data-Cyte Plus Day 0.8% Technical Name: ANTIBODIES / SYSTEMS FOR DIFFERENTIAL CELL COUNTING ANVISA Registration Number: 80134860207 Hazard Class: III Model Affected: Code 213627 Serial Numbers Affected: 611316015 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Medion Diagnostics Grifols 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
    2061
  • 날짜
    2017-01-27
  • 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
    Discontinue use of the product and send / return affected panels to destruction. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • 원인
    Through in-house tests, data-cyte plus day # 12 cell day 0.8%, lot: 611316015, validity 28-01-2017 has been identified that can react falsely positive with serum / plasma samples containing no unexpected antibodies. preliminary results from the internal investigation have shown that false positive results may be due to blood reagent cells or a combination of blood reagent cells and dg gel card. the equipment was excluded as a contributing factor because manual tests without the equipment confirmed the observations. the risk analysis has shown that there is no harm to the patient and that the remaining risk is exclusively reduced to a delay in transfusion but in no case can result in a wrong transfusion due to the interpretation of the test.
  • 조치
    Field Action Code 2017-01 triggered under the responsibility of the company Grifols Brasil Ltda. Company will collect for further destruction of the product.

Device

Data-Cyte Plus Day 0.8% Technical Name: ANTIBODIES / SYSTEMS FOR DIFFERENTIAL CELL COUNTING ANVIS...

Manufacturer

Medion Diagnostics Grifols