Events

Device Recall GCX Mountable DownloaderRecharger; 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Point of Care 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
    56560
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2462-2010
  • 사례 시작날짜
    2010-08-20
  • 사례 출판 날짜
    2010-09-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94075
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • 원인
    Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
  • 조치
    Abbott Point of Care, Inc. sent Urgent Recall Notices, dated August 20, 2010, by Federal Express to two Clarion Health locations. The letter identified the product, the issue, and the actions to be taken by the firm and the customers. 1) An Abbott Point of Care representative will contact the customers to plan the replacement of affected product at their facility. 2) Replacement will occur in batches of approximately 50 units at a time. 3) Abbott will provide personnel to perform the replacements to help expedite the replacement. 4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice.. If you have any questions regarding this information please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.

Device

Device Recall GCX Mountable DownloaderRecharger;
  • 모델명 / 제조번호(시리얼번호)
    List number: 06F23-57/514005, part number 016060-01.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - USA, including the state of Indiana
  • 제품 설명
    GCX Mountable Downloader-Recharger; || (accessory to the i-STAT Portable Clinical Analyzer (model 300). || The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or "arm" and provide a data connection to an authorized manufacturer's patient monitoring systems.
  • Manufacturer
    Abbott Point of Care Inc.

Manufacturer

Abbott Point of Care Inc.
  • 제조사 주소
    Abbott Point of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA