Events

IMMULITE / IMMULITE 1000 Osteocalcin, Registration nº 10345161079 - Lots 316, 317 and 319. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda. 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
    1383
  • 날짜
    2014-05-02
  • 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
    The company reports that, based on research conducted, Osteocalcin may serve as a measure of increased bone resorption in some patients. Depending on the treatment approach, osteocalcin dosing may be correlated with therapy. In some patients the risk of osteoporosis correlates with increased osteocalcin values. Low recovery of osteocalcin is not expected to impact treatment.
  • 원인
    Siemens has confirmed an average low 50% recovery in patient values ​​over the entire reported range of the immulite / immulite 1000 osteocalcin (lkon1) test in the lots listed above, and the bias may not be detected by the quality control material.
  • 조치
    The company informs that customers were instructed to discontinue use of affected lots; to segregate remaining units in their inventories to collect them; discuss the alert message with the person in charge of the laboratory in order to evaluate the need to review previously released results; to complete the effectiveness verification form and to keep the letter filed with the laboratory records. For more information, see Annex I - Customer Letter.

Device

IMMULITE / IMMULITE 1000 Osteocalcin, Registration nº 10345161079 - Lots 316, 317 and 319.

Manufacturer

Siemens Healthcare Diagnósticos Ltda.