QUICKSTEP PLUS ONE STEP URINE PREGNANCY TEST 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 INNOVATEK MEDICAL 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
    83034
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-04-24
  • 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
    One end user has recently reported a random finding of anti-hiv tests inside some of the sealed quickstep plus pouches instead of hcg pregnancy tests. any anti-hiv tests found are not usable on their own and will not give any valid result as they lack other test components necessary to perform a test procedure. affected test cassettes have "anti-hiv" prominently embossed next to the reading window are smaller in size than pregnancy tests have a different configuration and lack the blue colour in the sample well that pregnancy test cassettes show. the expiry date is nearing on this lotand that all quickstep plus pregnancy test kits of lot number 04081 must be discarded after april 30 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 4220-33 (Lot serial: 04081)
  • 제품 설명
    Quickstep Plus one step urine pregnancy test
  • Manufacturer

Manufacturer