Events

Injection Pipette 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 The Pipette Company Pty Ltd 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-2018-RN-00170-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-02-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00170-1
  • 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
    The pipette company (tpc) has been made aware of a potential dimensional issue with the injection pipettes which may result in a narrow internal diameter (id) of the pipette tip. a narrow internal diameter, below the acceptance criteria, may cause technical difficulties, including aspiration of sperm as sperm cannot be loaded into an overly narrow injection pipettes.
  • 조치
    The Pipette Company is advising affected customers to complete the reply form supplied with the Customer Letter to schedule refund or exchange.

Device

Injection Pipette
  • 모델명 / 제조번호(시리얼번호)
    Injection PipettePart Number: LICR-0D5Multiple Affected Lot NumbersManufacturing dates: May 2017-October 2017ARTG Number: 160455(The Pipette Company Pty Ltd - Micropipette, user-induced)
  • Manufacturer
    The Pipette Company Pty Ltd

Manufacturer

The Pipette Company Pty Ltd