Events

Pipet Tips used with AutoDG System. An in vitro diagnostic medical device 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories 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-2017-RN-01481-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-12-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01481-1
  • 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
    This failure appears as low total volume in the well of the autodg droplet plate after automated droplet generation, and results in low droplet counts when analyzing data in quantasoft. the failure is most frequently observed in columns 2 and 8 of the droplet plate, which corresponds to the fourth column of pipet tips in each box (when loaded with the box label facing front). this issue may impact pipet tip lots listed in the product details table above shipped in 2017and is most frequently observed with pipet tips from column 4 of the pipet tip box. this defect has no safety or efficacy impact, and will not result in erroneous results.
  • 조치
    Bio-Rad has decided to continue to ship pipet tips with a short-term workaround detailed in the Customer Letter.

Device

Pipet Tips used with AutoDG System. An in vitro diagnostic medical device
  • 모델명 / 제조번호(시리얼번호)
    Pipet Tips used with AutoDG System. An in vitro diagnostic medical deviceProduct Number: 1864120, 1864121, 12003010Lot Numbers: PR136933, PR137957, PR138863, PR139939, PR136556, PR136109, PR134751, PR135656, PR135220ARTG Number: 296086
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd