UNICEL DXC 600 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 BECKMAN COULTER CANADA L.P. 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
    53044
  • 사례 위험등급
    III
  • 사례 시작날짜
    2015-07-17
  • 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
    Beckman coulter has identified a failure of the unicel dxc ise tubing (lines 11 25 and 26) for ise reference reagent. the failure occurs due to the interaction between a new tubing plasticizer and the ise reference reagent. the supplier's change in plasticizer was a result of a move to a phthalate-free tubing material based on new environmental regulations. as a result a slowforming non-microbial white material may appear inside the tubing. observed symptoms of the presence of the white material can include suppressed ion specific electrode (ise) quality control and patient results ise calibration failures and detached tubing lines 25 or 26 due to obstruction of flow. current investigation suggests it is highly unlikely that incorrect results will be generated.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 4764 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4773 (Lot serial: 3048); Model Catalog: 4773 (Lot serial: 4282); Model Catalog: 4767 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4771 (Lot serial: 4036); Model Catalog: 4768 (Lot serial: 4143); Model Catalog: 4768 (Lot serial: 2788); Model Catalog: 4768 (Lot serial: 3563)
  • 제품 설명
    UniCel DxC 600 SYNCHRON Clinical Systems
  • Manufacturer

Manufacturer