Events

COULTER ReticPrep Reagent Kit (used for reticulocyte counting). 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-00151-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-02-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00151-1
  • 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
    Beckman coulter has received an increased number of customer complaints related to the inability to scan or manually enter the reticprep barcode label. the reticprep barcode label number 2 contains characters that are not recognised by the software ("+$$" instead of "22"), and due to this issue the system will not generate results.The reported issue may lead to a delay in test results reporting. however, it is unlikely to cause adverse health consequences.
  • 조치
    Beckman Coulter is advising users to follow the IFU to manually enter barcode number 2 with "22" in place of "+$$" which is printed on the label.

Device

COULTER ReticPrep Reagent Kit (used for reticulocyte counting). An in vitro diagnostic medical de...
  • 모델명 / 제조번호(시리얼번호)
    COULTER ReticPrep Reagent Kit (used for reticulocyte counting). An in vitro diagnostic medical device (IVD)Reference Number: 7546978 Lot Number: 108912K Expiry Date: 11/12/2016ARTG Number: 223049
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd