Events

Device Recall iSTAT G3 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
    51211
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1541-2009
  • 사례 시작날짜
    2009-02-23
  • 사례 출판 날짜
    2009-06-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-07-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81617
  • 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
    Blood-Gases (PCO2, PO2) and Blood pH Electrode Measurement - Product Code CHL
  • 원인
    Equipment problem: i-stat cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
  • 조치
    Urgent Recall Notice letters pertaining to the EG7+ Cartridges were sent on February 23, 2009 by first class mail to all customers. The firm found one other affected lot of G3+ cartridges and expanded the recall to include one other lot. Letters for the expansion are dated May 2009. Customers were asked to use the attached form to record all of the box numbers if they have any cartridges from the affected lot. Cartridges from the box numbers listed will be replaced an any remaining unused cartridges from those specific boxes are to be returned as instructed on the form. To receive replacement cartridges, customers are to follow the instructions on the enclosed customer reply form. If any cartridges from the affected lot were forwarded to another facility, a copy of the recall letter needs to be provided to them and the information at the bottom of the customer reply form should be completed. Questions should be directed to 1-800-366-8020, Option 1.

Device

Device Recall iSTAT G3 Cartridge
  • 모델명 / 제조번호(시리얼번호)
    Lot P08321C, Abbott List number 06F03-01 (USA and Canada), Abbott List Number (rest of world) 06F03-02; Box numbers 1491 and 1534.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.
  • 제품 설명
    i-STAT G3+ Cartridge; || pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100. || Abbott Point of Care Inc., || Abbott Park, IL 60064 || The iSTAT G3+ Cartridge is intended to be used to quantitatively measure oxygen, carbon dioxide, and pH.
  • 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