UNICEL DXC 880I SYNCHRON ACCESS CLINICAL ANALYZER 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
    27982
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-03-20
  • 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
    1. when archiving to a usb flash drive if the calibrator name contains the forward slash "/" character the calibration report will not be archived for the affected calibrators. there is no warning or message to tell the customer that the calibration report has not been archived. calibrator archive reports for these calibrations are not created and the calibration information is not available to download to the usb flash drive. calibrators affected: iron/ibct lx/dxc apo (lx/dxc apo cal on the cal disk) lx/dxc ma lx/dxc pab. 2. when upgrading from one version of 5.0 to another the calibration files that are older than the most recent five calibrations but have not been archived to the usb flash drive are not transitioned to the new version of software. as a result these calibration files are not available to download to the usb flash drive after the upgrade. this issue also affects a "parallel upgrade" in which the same version of 5.0 software is reinstalled on the system.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: A59102 (Lot serial: 4143); Model Catalog: 4768 (Lot serial: 4143); Model Catalog: A59102 (Lot serial: 3563); Model Catalog: 4768 (Lot serial: 3563); Model Catalog: A59102 (Lot serial: 2788); Model Catalog: 4768 (Lot serial: 2788); Model Catalog: 4764 (Lot serial: > 10 numbers contact mfg); Model Catalog: A11816 (Lot serial: > 10 numbers contact mfg); Model Catalog: A64935 (Lot serial: 4282); Model Catalog: 4773 (Lot serial: 4282); Model Catalog: 4767 (Lot serial: > 10 numbers contact mfg); Model Catalog: A10405 (Lot serial: > 10 numbers contact mfg); Model Catalog: A27318 (Lot serial: > 10 numbers contact mfg)
  • 제품 설명
    UNICEL DXC 880I SYNCHRON ACCESS CLINICAL ANALYZER
  • Manufacturer

Manufacturer