Events

ADVIA Chemistry ALP (AMP) Reagents - Registration No. 10345160518. Lots: R1: 7X38mL - R2: 7X11,7mL (7 x 357 tests); R1: 4X38 mL-R2: 3X15mL (4 x 350 tests). Lots: 327460 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A. 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
    1701
  • 날짜
    2015-10-21
  • 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 has identified that the increase in the incidence of absorbance flags associated with lots of reagents is not related to inaccurate results. If results of calibrations and quality controls are acceptable, reported patient outcomes are also acceptable.
  • 원인
    Siemens healthcare has confirmed that the alkaline phosphatase reagents contained in the portuguese letter chc 15-16 (alert message) used in the advia chemistry 1200, 1800, 2400 and xpt systems have shown an increase in the incidence of flags (u and u) and errors // //. the absorbance flags u and u indicate high absorbance, exceeding the boundary values ​​defined in the test protocol for blank or sample limits. the absorbance flags //// indicate an error in the calculation, not allowing the generation of results by the system.
  • 조치
    Siemens Healthcare recommends the following actions: - Discontinue use and discard batches of reagents identified in this Field Action; - Keep the Portuguese Letter CHC 15-16 (Alert Message) in your laboratory records for any future consultations.

Device

ADVIA Chemistry ALP (AMP) Reagents - Registration No. 10345160518. Lots: R1: 7X38mL - R2: 7X11,7m...

Manufacturer

Siemens Healthcare Diagnósticos S.A.