Events

Hand-held Barcode Scanner used with VITROS clinical chemistry systems. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 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-2015-RN-00033-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00033-1
  • 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
    Ortho clinical diagnostics (ocd) has received a report that when using a hand-held barcode scanner in combination with use of the batch programming option for programming samples, the scanner unexpectedly skips sample cup positions. for example, a sample tube barcode is scanned for the cup 1 position, the cursor in the batch programming screen skips the cup 2 position and advances to the cup 3 position. if this anomaly occurs, there is a potential for mis-associated results.
  • 조치
    OCD is providing instructions on the reprogramming of the barcode scanner. Once the barcode scanner is reprogrammed the issue will not occur. This action has been closed-out on 15/07/2016

Device

Hand-held Barcode Scanner used with VITROS clinical chemistry systems. An in vitro diagnostic med...
  • 모델명 / 제조번호(시리얼번호)
    Hand-held Barcode Scanner used with VITROS clinical chemistry systems. An in vitro diagnostic medical device (IVD).Product Code: 6844210ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics