MATCH IT TM DNA SOFTWARE V 1.2 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 IMMUCOR GTI DIAGNOSTICS INC. 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
    44984
  • 사례 위험등급
    II
  • 사례 시작날짜
    2018-02-11
  • 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
    It has been determined that when using match it! dna software v1.2.3 (with the pairwise functionality turned off) on a win 7 32-bit computer to analyze hla-a typing the software does not correctly load the suggested assignment table when navigating between samples that contain complex numbers of hla-a allele-string pairs. when the user navigates from one sample to the next the software does not automatically assign a typing into the assigned view field when the auto assign feature is activated in preferences. if the user attempts to make a manual assignment to the assigned view field the software will crash. it has also been determined that there is a possibility of a mistype when using match it! dna software v1.2.4 (with the pairwise functionality turned off) on a win 7 32-bit computer to analyze hla-a typing. if the user navigates from one sample to the next sample the software can maintain the previous sample typing in the assigned view field in addition to the suggested assignments. if the user attempts to make a manual assignment the software will freeze. there is no warning that the typing in assigned view is incorrect.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 888623 (Lot serial: NA)
  • 제품 설명
    MATCH IT! DNA SOFTWARE
  • Manufacturer

Manufacturer

  • 제조사 주소
    WAUKESHA
  • 제조사 모회사 (2017)
  • Source
    HC