MICROSCAN NEG BP COMBO PANEL 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS HEALTHCARE 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
    53867
  • 사례 위험등급
    III
  • 사례 시작날짜
    2014-08-14
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    A technical suppot bulletin (tsb-190) provided instructions for creating new labpro ast interpretation action alert rules to enable reporting of the new enterobacteriaceae breakpoints on microscan dried gram negative mic/combo panel types containing the lower imipenem (imp) dilutions. however the tsb did not mention the performance limitation for the enterobacteria proteus mirabilis and imipenem for which the revised interpretive criteria may result in minor errors with clinical p. mirabilis isolates. therefore the drug name minimal inhibitory concentration (mic) and interpretation should not be reported for p. mirabilis and imp on the microscan dried gram negative mic/combo panels listed in (1).

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: B1017-417 (Lot serial: >100 numbers contact mfg); Model Catalog: B1017-412 (Lot serial: >100 numbers contact mfg); Model Catalog: B1027-101 (Lot serial: >10 numbers contact mfg); Model Catalog: B1017-407 (Lot serial: >1000 numbers contact mfg); Model Catalog: B1017-409 (Lot serial: >1000 numbers contact mfg); Model Catalog: B1017-414 (Lot serial: >1000 numbers contact mfg)
  • 제품 설명
    Microscan NEG bp cOMBO pANEL
  • Manufacturer

Manufacturer

  • 제조사 주소
    OAKVILLE
  • 제조사 모회사 (2017)
  • Source
    HC