VYSIS PARAFFIN PRETREATMENT KIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 INTER MEDICO 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
    115112
  • 사례 위험등급
    III
  • 사례 시작날짜
    2017-10-26
  • 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 was recently identified that some vysis paraffin pretreatment reagent kits may have been distributed with an incorrect lot number printed on the packaging labeling. the kit lot number appears in three places on the vysis paraffin pretreatment reagent kits: 1. the abbott molecular certificate of analysis that is packed within each kit 2. the label which is placed on the kit carton and 3. the label which is placed on the outer sleeve that goes over the kit carton. the correct lot number is 2087c172 and it is correctly printed on the certificate of analysis that is packaged within each kit. although unlikely an incorrect lot number (2347c384) may have been printed on the kit carton label and/or on the outer sleeve label.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 02J02-032 (Lot serial: 2087C172)
  • 제품 설명
    VYSIS PARAFFIN PRETREATMENT KIT
  • Manufacturer

Manufacturer

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