Events

CREATININE PAP FS-R1 1x800 ml + R2 1x400 ml; R1 4x100 ml + R2 2x100 ml; R1 6x40 ml + R2 6x20 ml - 2040 automated determinations; R1 4x34.9 mL + R2 4x19.3 mL - 800 automated determinations - ALL IMPORTED LOTS. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BIOSYS 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
    1183
  • 날짜
    2012-09-25
  • 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
    There is a median probability of an incorrect creatinine value occurring in urine samples from patients with alkaptonuria (due to homogentisic acid). The severity and estimated risk is low if the test results are assured by the laboratory's internal quality control. The results of the tests should be checked critically by the health professional. Anvisa accompanies this Action. #### TERMINATION - 03/10/2012 - The company forwards Notice of Completion of the Field Action.
  • 원인
    High concentrations of hga in urine samples may interfere with photometric measurement with the enzymatic creatinine method and to a lesser extent with the jaffé method.
  • 조치
    The results of the tests must be ensured by the internal quality control of the laboratory. The results of the tests should be checked critically by the health professional. In addition, the health professional should evaluate the need for confirmatory tests, as well as take into consideration the patient's medical history and examination. In case of a discrepant result with the patient's clinic, confirm the result using a different method. Check the instruction for use of the product to evaluate information on possible interference.

Device

CREATININE PAP FS-R1 1x800 ml + R2 1x400 ml; R1 4x100 ml + R2 2x100 ml; R1 6x40 ml + R2 6x20 ml -...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    BIOSYS LTDA

Manufacturer

BIOSYS LTDA