Events

Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser, COBAS INTEGRA 800 analyser and cobas c 501/502 modules. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty Limited 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-01306-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01306-1
  • 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
    There is a potential for elevated recoveries from patient samples when using individual c packs of tina-quant hba1c gen.2. this phenomenon has been noticed across multiple lots when the reagent has inadvertently been frozen. this issue may lead to erroneously high hba1c results.
  • 조치
    Users are to ensure the correct storage conditions of +2 to +8 °C are maintained as per IFU and if freezing was suspected, a control measurement should be performed. It was also recommended at this time to perform QC on each reagent cassette. Users are to carry out QC every 24 hr when using the cassette, and with each new cassette. If QC cannot be kept within the specified range, the respective reagent cassette should not be used for further measurement. Consider switching to the Gen.3 reagent which is less susceptible to low temperatures.

Device

Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser, COBAS INTEGRA 800 ana...
  • 모델명 / 제조번호(시리얼번호)
    Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser, COBAS INTEGRA 800 analyser and cobas c 501/502 modules. An in vitro diagnostic medical device (IVD).Material Number: 04528123190Lots affected: AllARTG Number: 174909
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited