Events

EZ-Strip 145ìm (Assisted reproduction microtool) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Key IVF Supplies 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
    RC-2016-RN-01286-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01286-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    It has been reported that an ez-strip product from the stated lot may contain debris that could result in the device failing to perform its intended purpose. this fault, if not identified by the customer could result in the loss of oocytes.
  • 조치
    Key IVF Supplies are advising customers to cease use of the affected lot and immediately quarantine all remaining packs. Key IVF will arrange for the collection of the quarantined packs and will replace affected stock. This action has been closed-out on 02/03/2017.

Device

EZ-Strip 145ìm (Assisted reproduction microtool)
  • 모델명 / 제조번호(시리얼번호)
    EZ-Strip 145ìm (Assisted reproduction microtool) Part Number: 7-72-1145/20Lot Number: 150299-01Expiry Date: June 2018
  • Manufacturer
    Key IVF Supplies

Manufacturer

Key IVF Supplies