Events

Device Recall ARCHITECT LH Reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories MPG 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
    36889
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0488-2007
  • 사례 시작날짜
    2006-11-22
  • 사례 출판 날짜
    2007-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-12-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49522
  • 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
    in vitro diagnostic - Product Code CEP
  • 원인
    The lots of architect lh reagent list 6c25-22, have the potential to generate patient specimen results that are elevated. correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed.
  • 조치
    Abbott initiated a field correction recall by letter dated 11/22/06 to all customers receiving the affected reagent. The accounts were informed of the elevated patient results with the affected lots of reagents. The accounts were requested to assess the inventory for the affected lots of reagents, discontinue use of the lots and destroy the remaining inventory of the lots, recording the number of kits on the customer reply form and faxing it to Abbott by 12/6/06, indicating that the letter was received and understood. Credit will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.

Device

Device Recall ARCHITECT LH Reagent
  • 모델명 / 제조번호(시리얼번호)
    lot numbers 33198M200 and 41861M100, 33198M201, and 33871M100. All lots expire 6/16/2007.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.
  • 제품 설명
    ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

Abbott Laboratories MPG
  • 제조사 주소
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA