Events

CELLDYN 3700 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories 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
    56309
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2351-2010
  • 사례 시작날짜
    2010-04-16
  • 사례 출판 날짜
    2010-09-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93216
  • 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
    Differential Cell Counter - Product Code GKZ
  • 원인
    Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
  • 조치
    Product Recall letters were sent on 04/16/2010. The letters identified the affected product, explained the reason for recall, the patient impact/user safety, stated the necessary actions, and contact information. Users are to discontinue use until the Waste Chamber(s) have been replaced and follow the instructions in the Hazards section. In addition, appropriate protective equipment needs to be worn along with following their recommended laboratory procedures dealing with spills. Users are to contact their local Abbott Customer Support rep. US customers should be direct their questions to Customer Support.

Device

CELLDYN 3700
  • 모델명 / 제조번호(시리얼번호)
    Reservoir Date Codes Dec 17 2009 to March 17, 2010. Part Number/Serial numbers-- CS: 02H30-01/20478AN, 20479AN SL: 02H31-01/22470AK, 21690AK, 22062AK, 21699AK, 20756AK, 22459AK, 21302AK, 21601AK, 22753AK
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.
  • 제품 설명
    CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 제조사 주소
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA