Events

Device Recall M53D Diluent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mindray DS USA, Inc. dba Mindray North America 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
    79556
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1321-2018
  • 사례 시작날짜
    2018-01-24
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162631
  • 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
    Diluent, blood cell - Product Code GIF
  • 원인
    Certain lots of m-30d diluent used with bc-3200 and bc-3600 hematology analyzers and m-53d diluent used with bc-5390 hematology analyzer may cause the system to produce an elevated platelet background count.
  • 조치
    Letters dated January 24, 2018, were sent to consignees with the following instructions: The issue manifests intermittently, therefore, you may continue to use affected lots if the background check is successfully completed. Discard affected lots which cause the system to display the error message background abnormal. Mindray will replace the potentially affected lots at no cost. Please contact Technical Support to order replacement product. For further questions, please call (201) 995-8407.

Device

Device Recall M53D Diluent
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
  • 제품 설명
    Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) || The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America