Roche Accu-Chek Inform 11 Base Unit and Handheld Base Unit 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 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
    20444
  • 사례 시작날짜
    2016-07-28
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 원인
    Some accu-chek® inform ii base units (bu) and handheld base units might produce transmission errors in the form of data loss in the usb communication between the meter and the dms; for example, cobas it 1000 or any other 3rd party software. this could happen in rare cases when the base unit is connected via usb connection to a pc. this may be indicated by numerous (nonspecific) error messages sent from the meter to the dms in the form of unexpected software failure 11800 events.
  • 조치
    Software to be upgraded

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: 05060290001 and 04805658001, Affected: , Software version: 3.00.00
  • Manufacturer

Manufacturer