Events

Device Recall Architect Free T4 Calibrator Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories HPD/ADD 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
    26430
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1132-03
  • 사례 시작날짜
    2003-05-30
  • 사례 출판 날짜
    2003-08-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-09-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27669
  • 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
    Radioimmunoassay, Free Thyroxine - Product Code CEC
  • 원인
    The free t4 controls, may yield control values that are high and outside of the package insert ranges.
  • 조치
    The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, were recalled by letter dated 5/30/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the IMx kit, and were requested to discontinue use and destroy the affected lots of product. Abbott sent a Device Correction letter dated 6/4/03 to those accounts receiving the Architect Free T4 Calibrator kits, informing them of the problems experienced with the The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, made from the same raw material. The accounts were informed that the Architect Calibrator was performing as expected, but as a precaution recommended conducting a daily QC with non-Abbott Controls and to report back to Abbott any out of range non-Abbott control results.

Device

Device Recall Architect Free T4 Calibrator Kit
  • 모델명 / 제조번호(시리얼번호)
    list 7G96-01, lot number 94493M300
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and internationally to Abbott subsidiaries in Ecuador, Uruguay, Argentina, Brazil, El Salvador, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Costa Rica, Grenada, St. Lucia, Bermuda, Antigua, Panama, Guatemala, Mexico, Colombia, Jamaica, Paraguay, Peru, Chile, Dominican Republic, United Kingdom, New Zealand, Trinidad & Tabago, St. Vincent, Barbados, Curacao, St. Kitts, Anguilla, Turks & Caicos Islands, Cayman Islands, Germany and Taiwan.
  • 제품 설명
    Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories HPD/ADD

Manufacturer

Abbott Laboratories HPD/ADD
  • 제조사 주소
    Abbott Laboratories HPD/ADD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA