Events

Device Recall iSTAT 6 cartridges 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
    54652
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1796-2010
  • 사례 시작날짜
    2010-02-05
  • 사례 출판 날짜
    2010-06-11
  • 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=88901
  • 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
    Device, Hemocrit measuring - Product Code JPI
  • 원인
    Abbott has determined that there is a dependence of the i-stat hct assay on the vertical pitch angle of the i-stat analyzer during the blood analysis cycle.
  • 조치
    The firm, Abbott Point of Care, sent an "Urgent Field Safety Notice Product Recall" letter dated January 2010 to the customers. Safety Alert /Product Recall letters were also sent by Federal Express commencing on February 5, 2010. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to replace the i-STAT Hematocrit/HCT and Calculated Hemoglobin/HB /Cartridge and Test Information (CT) Sheet found in their i-STAT System manual with those included in the mailing , and to provide a copy of the letter another facility, if they have forwarded any cartridges. If you should have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020 or your Abbott Point of Care representative.

Device

Device Recall iSTAT 6 cartridges
  • 모델명 / 제조번호(시리얼번호)
    List # 06F05-01, 02
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and Argentina; Austria; Bahamas; Bolivia; Brazil; Chile; Hong Kong; China; China; Columbia; Costa Rica; Denmark; Dominican Republic; Ecuador; El Salvador; Finland; Georgia; Greece; Honduras; India; India; Ireland; Israel; Italy; Japan; Kuwait; Mauritius; Mexico; Norway; Oman; Panama; Paraguay; Peru; Poland; Portugal; Qatar; Russian Federation; Saudi Arabia; Singapore; South Africa; South Korea; Spain; Switzerland; Taiwan; Thailand; Trinidad and Tobago; Turkey; United Arab Emirates; Uruguay; Yemen; Netherlands Antilles; Venezuela; Australia; Belgium; France; Germany; Italy; New Zealand; Spain; Sweden; and The Netherlands.
  • 제품 설명
    i-STAT 6+ cartridges || The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.
  • 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