Events

TOSOH G7 HPLC automated system analyzer 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Tosoh AIA 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
    I1703-94
  • 사례 연번
    2009DM-0004739
  • 날짜
    2017-03-13
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that the referenced medical devices can give hba1c values with a negative bias for patients with variants of hemoglobin c, d, e and s with higher levels of hba1c (for example, 9%), but not at the level of medical diagnosis. 6.5%, which could lead to delays in the processing of samples.

Device

TOSOH G7 HPLC automated system analyzer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The TOSOH G7 HPLC automated system analyzer is a fully automated high-performance liquid chromatography instrument that rapidly and precisely separates hemoglobins found naturally in the blood. Glycosylated hemoglobins and other components of hemoglobin are extracted depending on the charge of the molecule in relation to an incremental gradient that pass through a non-porous cationic column. In the mode of HbA1c variant analysis, the predetermined windows are configured in the software to detect the presence of HbA1a, HbA1b, HbF, labile HbA1c (la1c), HbA1c (sa1c), and a0. The reagents that are used with the TOSOH G7 analyzers have a respective health record.
  • Manufacturer
    Tosoh AIA

Manufacturer

Tosoh AIA