SSP UNITRAY - HIGH RESOLUTION CLASS I 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 LIFE TECHNOLOGIES CORPORATION 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    22791
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-02-14
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    The kits will produce an incorrect typing or mistyping result of a c*07:18 allele when testing a sample which has a c*07:01:03 allele. primer mix c07-06b found on lane 42 in the cw high resolution allset gold and ssp unitray high resolution kits was found to contain a false positive for c*07:01:03. c*07:01:03 has an unknown sequence at the priming site and was incorrectly predicted to be negative in lane 42 in the kit documentation. after analysis we have confirmed that lane 42 now amplifies the c*07:01:03 allele. this discrepancy does not result in a common allele mistyping.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 47190-10 (Lot serial: 005 791450); Model Catalog: 47190-10 (Lot serial: 005 839297); Model Catalog: 47190-10 (Lot serial: 005 889242); Model Catalog: 47190-10 (Lot serial: 005 1103812); Model Catalog: 47190-10 (Lot serial: 005 1011640); Model Catalog: 54030D (Lot serial: 005 1091906); Model Catalog: 54030D (Lot serial: 005 932215); Model Catalog: 54030D (Lot serial: 005 874256); Model Catalog: 47190-10 (Lot serial: 005 749777); Model Catalog: 54030D (Lot serial: 005 757723); Model Catalog: 47190-10 (Lot serial: 005 928442)
  • 제품 설명
    Invitrogen Cw High Res Unitray SSP Kits
  • Manufacturer

Manufacturer