Events

Sample Probe Connector used with cobas 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-2017-RN-00398-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00398-1
  • 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
    Roche has identified that in very rare cases, a disturbance of the sample liquid level detection (lld) may occur due to a fretting corrosion on the sample probe connector. in such instances, the affected sample probe may not aspirate the sample material at the correct level; accordingly the probe may not be washed adequately, resulting in the possibility of sample carryover.This issue, which was detected during an internal investigation, was caused by a production change in the sample probe connector type, potentially causing fretting corrosion on the sample probe connector. to date, roche have not received any complaints about this issue.
  • 조치
    Roche is requesting that customers check the sample probe in use in their analyser to determine if the sample probe is from the potentially affected serial/lot numbers. If so, customers are advised to contact Roche to discuss an exchange. Until the sample probe is exchanged, users are requested to follow the detailed instructions provided in the customer letter.

Device

Sample Probe Connector used with cobas modules. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Sample Probe Connector used with cobas modules. An in vitro diagnostic medical device (IVD)Probe SampleMaterial Number: 04547241001Systems affected: cobas c 501/502/701/702 modulesSample ProbeMaterial Number: 04945794001Systems affected: cobas 8000 ISE module 1800Multiple Serial NumbersARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited