IRMA TRUPOINT BLOOD ANALYSIS SYSTEM - BG CARTRIDGE (PH PCO2 PO2) 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 LIVANOVA CANADA CORP. 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
    19367
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-12-17
  • 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
    Affected lots may report values outside the published performance specifications for ph. the discrepancy is greater as shelf life progresses and high ph is observed on aqueous qc before blood is affected. the largest discrepancy on blood that has been identified is +0.05 ph units.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 048103 (Lot serial: EOSCU); Model Catalog: 048103 (Lot serial: EOTUZ); Model Catalog: 048103 (Lot serial: EOVMW); Model Catalog: 048103 (Lot serial: EOYUL); Model Catalog: 048103 (Lot serial: EPANW); Model Catalog: 048103 (Lot serial: EPCED); Model Catalog: 048103 (Lot serial: EPDVM); Model Catalog: 048103 (Lot serial: EPFOJ); Model Catalog: 048103 (Lot serial: EPIXX); Model Catalog: 048103 (Lot serial: EPKOJ); Model Catalog: 048103 (Lot serial: EPNXA); Model Catalog: 039903 (Lot serial: ASRXC); Model Catalog: 039903 (Lot serial: ASCXE); Model Catalog: 039903 (Lot serial: ASEMB); Model Catalog: 039903 (Lot serial: ASHWQ); Model Catalog: 039903 (Lot serial: ASWZI); Model Catalog: 039903 (Lot serial: ASTQR); Model Catalog: 039903 (Lot serial: ASBEZ); Model Catalog: 039903 (Lot serial: ASOQO); Model Catalog: 039903 (Lot serial: ASMXR); Model Catalog: 039903 (Lot serial: ASLGI); Model Catalog: 039903 (Lot serial: ASJMY)
  • 제품 설명
    IRMA TRUPOINT BG CARTRIDGES
  • Manufacturer

Manufacturer

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