Biotestcell I8, Biotestcell I11 and Biotestcell I11E 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Bio-Rad 에 의해 제조된 제품과 관련되어 있습니다.

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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
  • 날짜
    2014-06-20
  • 사례 출판 날짜
    2014-06-20
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: bio-rad biotestcell i8, biotestcell i11 and biotestcell i11e medical device manufacturer, bio-rad, has issued a field safety notice (fsn) concerning biotestcell i8 (code no. 816 020), biotestcell i11 (code no. 816 021) and biotestcell i11e (code no. 816 051). the affected lot number is 2422011-00. due to subsequent exchange of one donor cell in the cell panel of the products mentioned above, an incorrect version of the worksheet was used for packaging. this worksheet contains incorrect information for cell i7. with this incorrect worksheet an identification of anti-jkb, -s and -s antibodies is not possible. misinterpretations do not occur. using the affected reagents as control reagent will lead to a discrepant result misleadingly indicating a problem with the tested reagent (e.G. seraclone anti-jkb, anti-s, anti-s). the manufacturer advises users not to use worksheets included in the packages of the lots mentioned above. a fsn with corrected worksheets containing correct donor information for cell i7 was issued to alert users. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 jun 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Bio-Rad Biotestcell I8, Biotestcell I11 and Biotestcell I11E
  • Manufacturer

Manufacturer