Events

Device Recall UniCel DxH 600 Coulter Cellular Analysis System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter Inc. 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
    78611
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0237-2018
  • 사례 시작날짜
    2017-11-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159890
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Counter, differential cell - Product Code GKZ
  • 원인
    The shield for the single-tube station on the dxh instrument may interfere with sample aspiration in the open vial position.
  • 조치
    The firm notified its consignees of the recall on 11/03/2017 by letter. The letter stated the issue and provided the following instructions: ¿ "To avoid a biohazardous spill, do not use the right (green) position of the Single-Tube Station for sample aspiration until the shield is removed. ¿ You may remove the shield following the instructions in Attachment 1 or contact your local Beckman Coulter Representative for further assistance."

Device

Device Recall UniCel DxH 600 Coulter Cellular Analysis System
  • 모델명 / 제조번호(시리얼번호)
    Serial Number AZ06682
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, AR, HI, CA, OH, WA, MD, Canada, Japan
  • 제품 설명
    UniCel DxH600, Part Number B23858, automated hematology analyzer || (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA