SSP UNITRAY - HIGH RESOLUTION CLASS II 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
    98310
  • 사례 위험등급
    III
  • 사례 시작날짜
    2014-02-27
  • 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
    There are three reactivity updates with respect to these kits: 1. in primer mix dpb004 (lane 4) the reactivity for the dpb1*31:01 has been updated from positive to negative. prior to this update in the presence of the dpb1*31:01 allele users may have obtained a negative reaction leading to a no-type result. 2. in primer mix dpb027b (lane 27) and dpb039a (lane 39) the reactivity for the dpb1*88:01 allele has been updated from positive to negative. prior to this update in the presence of the dpb1*88:01 allele users may have obtained a negative reaction leading to a no-type result. 3. in primer mix dpb039a (lane 39) the reactivity for the dpb1*29:01 allele has been updated from positive to negative. prior to this update in the presence of the dpb1*29:01 allele users may have obtained a negative reaction leading to a no-type result.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 451606D (Lot serial: > 10 numbers contact mfg); Model Catalog: 451616D (Lot serial: > 10 numbers contact mfg); Model Catalog: 54070D (Lot serial: 008 1127336); Model Catalog: 54070D (Lot serial: 008 1204422); Model Catalog: 54070D (Lot serial: 008 1256851); Model Catalog: 54070D (Lot serial: 009 1377591); Model Catalog: 54070D (Lot serial: 008 1073448)
  • 제품 설명
    DPB1 SSP UNITRAY 12 TESTS DPB1 SSP UNITRAY W/TAQ 12 TEST
  • Manufacturer

Manufacturer