Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IVD)(Point of Care System) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Australasian Medical & Scientific 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-2013-RN-01322-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-16
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    This recall action is to alert users that lithium batteries utilized beyond their intended useful life may swell and/or crack the external case posing a potential safety hazard. in some cases, the swelling may cause the battery door on the meter to incorrectly seat rendering the meter inoperable.
  • 조치
    AMSL is advising users that all batteries without an expiration date label will be replaced. AMSL recommends a battery inspection program is implemented to identify and remove batteries from point of use that do not have expiration dates on the battery label.

Device

  • 모델명 / 제조번호(시리얼번호)
    Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IVD)(Point of Care System)ARTG Number: 197482
  • Manufacturer

Manufacturer