Events

iStat1 Analyzer 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
    62319
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1973-2012
  • 사례 시작날짜
    2011-09-08
  • 사례 출판 날짜
    2012-07-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110215
  • 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 CHL
  • 원인
    Some i-stat analyzers become uncomfortably hot to touch in the are of the battery. this is a recall extension.
  • 조치
    Abbott Point Care sent an Urgent Product Recall letter dated September 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm the number of affected product at their facility that were using the Old Battery Carrier. Fill out the affected Buesiness Reply Card and submit their facility information as per the instructions on the card. Upon the receipt of the New Battery Carriers, replace the Old Battery Center with the New Battery Center. Customers were instructed to immediately dispose of all Old Battery Carriers per local regulations. If customers forward the affected product to another facility, they should provide a copy of the recall letter to them and advise them to replace the carriers if required. For any questions call 800-366-8020, Option 1 or your Abbott Point of Care representative. For questions regarding this recall call 609-454-9272.

Device

iStat1 Analyzer
  • 모델명 / 제조번호(시리얼번호)
    510K K940918  Product Number/List Number  06F16-05; 06F16--10; 310000; 310001;; 310002 All lots
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide)
  • 제품 설명
    iStat1 Analyzer || Abbott Point of Care, Princeton, NJ 08540 || Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels.
  • 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