Events

Device Recall Abbott Clinical Chemistry Albumin BCG (AlbG) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories 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
    55440
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1434-2012
  • 사례 시작날짜
    2010-03-10
  • 사례 출판 날짜
    2012-04-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90864
  • 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
    Bromcresol green dye-binding, albumin - Product Code CIX
  • 원인
    Observed particulate matter in some reagent cartridges.
  • 조치
    Abbott Laboratories sent a Product Recall notification letter dated March 10, 2010, to all affected customers. The notification letter contained an explanation, patient impact, neccassary actions, and contact information. Customers were instructed to determine if they currently have any of the affected product in their inventory. Discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures. Completed the enclosed Customer Reply Form. If customers forwarded any of the affected product they should provide a copy of the notification letter to their customers. For any questions customers should call Customer Service at 1-877-422-2688. For questions regarding this recall call 626-440-0705.

Device

Device Recall Abbott Clinical Chemistry Albumin BCG (AlbG)
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 77056HW00; 80051HW00; 83030HW00 Exp dates: 04/15/2011, 07/15/2011, and 10/10/2011, respectively.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US nationwide and internationally to Germany, Hong Kong, Australia, New Zealand, Trinidad/Tobago, and Jamaica. No dsitribution of Canada or Mexica.
  • 제품 설명
    Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 || Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX || The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

Abbott Laboratories Inc.
  • 제조사 주소
    Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA