Events

IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter Australia 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-2016-RN-00437-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00437-1
  • 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 manufacturer, iris international has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the irispec ca bilirubin control material. the control may fail for the bilirubin analyte and laboratories will be unable to process patient samples until qc passes.
  • 조치
    Beckman Coulter is advising users to ensure the directions for handling and storage of the control material as per the IFU are followed to prevent premature degradation of the control material. Users are advised to discard the bottle if the QC fails and use alternative bottles in the kit. If the problem persists, request a product replacement from Beckman Coulter. This action has been closed-out on 03/02/2017.

Device

IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin)....
  • 모델명 / 제조번호(시리얼번호)
    IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin). An in vitro diagnostic medical device (IVD)Reference Number: 800-7211Lot Numbers: 336-15, 343-15 (Exp April 2016) Lot Numbers: 004-16,006-16,019-16,021-16,182-15 (Exp May 2016)Reference Number: 800-7702Lot Numbers: 313-15, 336-15 (Exp April 2016) Lot Numbers: 004-16 (Exp May 2016)Reference Number: 800-7211Lot Number: 309-15 (Exp April 2016)ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd