Events

Product Name: PSA Third Generation IMMULITE / IMMULITE 1000 Technical Name: SPECIFIC PROSTATE ANTIGEN (PSA) ANVISA Registration Number: 10345160987 Hazard Class: III Affected Model: 100 Test Kit / 500 Test Kit Serial Numbers Affected: 336; 337 and 338 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Products Ltd. 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
    2072
  • 날짜
    2017-01-12
  • 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
    Siemens recommends the discontinuation and discontinuation of the mentioned lots and subsequent replacement request. The company does not recommend a review of previously generated results. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • 원인
    Siemens identified negative bias for batches 0336 and 0337 of the 3rd generation immulite psa (prostate specific antigen) assay. research by siemens has confirmed that patient samples may display a negative mean bias of approximately -22% with a range of -16% to -27% for samples ranging from 0.08 to 16.2 ng / ml. quality controls demonstrate a negative bias similar to those found in patient outcomes. depending on the quality control ranges used in your lab, this problem may not be identified by your qa material. a preliminary investigation at siemens indicates that the root cause of the negative bias is related to the adjusters used in kit lots 0336 and 0337. however, siemens has not yet confirmed a negative bias in kit lot 0338 until now, this lot is being included in this notice because this kit has the same batches of adjusters from lot kits 0336 and 0337. subsequently, 3rd generation immulite / immulite 1000 psa batches that do not have impacted lot adjusters in the kit will not be affected.
  • 조치
    Field Action BMI Code 17-05 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Product Name: PSA Third Generation IMMULITE / IMMULITE 1000 Technical Name: SPECIFIC PROSTATE ANT...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Products Ltd.