Events

iSTAT CREA Cartridge 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
    44972
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0373-2008
  • 사례 시작날짜
    2007-10-18
  • 사례 출판 날짜
    2007-12-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-07-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64693
  • 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
    Ion Specific Electrode (Sodium) - Product Code JGS
  • 원인
    Difficult to close -- certain lots of i-stat cartridges are difficult to close, will not close or do not stay closed.
  • 조치
    Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.

Device

iSTAT CREA Cartridge
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 06F10-01; 06F10-02 Lot Numbers: A07149; A07150; G07121; G07148; G07150; G07151; G07151A; G07157; G07158; and G07164A.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution- including USA and country of Canada.
  • 제품 설명
    Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No: 320100; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
  • Manufacturer
    Abbott Point of Care Inc.

Manufacturer

Abbott Point of Care Inc.
  • 제조사 주소
    Abbott Point of Care Inc., 104 Windsor Center Dr, East Windsor NJ 08520
  • 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