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DiaMed Q.C. System 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Bio-Rad 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-09-06
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    We have been made aware that samples of the product diamed q.C. system, ihd lot n° 45950 46 1 and 45950 47 1 show excessive hemolysis in samples 1 and 4 and weakly in sample 2. a risk assessment has been performed and no patient risk has been identified. you may continue to use the hemolysed cells äs lang äs they give the expected results and we kindly ask you to scrap all remaining kits of these above mentioned lots äs soon äs you get the replacement lots. tests have been performed internally and we can confirm that currently a clear result is returned with manual testing and on the saxo- swing, ih-1000 with the hemolysed qc samples. with ih-500 we may observe uninterpretable results on reverse grouping. in this case, please use another sample to perform the reverse grouping. note: tests involving serum 1 and serum 2 are in no way affected.

Device

DiaMed Q.C. System
  • 모델명 / 제조번호(시리얼번호)
    Mat. n° 45950 Lot No IHD 45950 46 1 45950471 Lot No SAP 166035461 172383471 Expiry Date 25.09.2017 09.10.2017
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad