Events

Device Recall Clinical Chemistry Total Bilirubin 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
    52748
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1425-2012
  • 사례 시작날짜
    2009-07-09
  • 사례 출판 날짜
    2012-04-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83856
  • 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
    Diazo colorimetry, bilirubin - Product Code CIG
  • 원인
    Abbott laboratories has issued a recall on the clinical chemistry total bilirubin due to an under-recovery on one clinical neonatal specimen resulting in a value less than the assay linear limit.
  • 조치
    Abbott Laboratories plans to release a Product Correction letter to customers instructing customers to follow the steps provided in order to revise their Total Bilirubin assay parameters. The letter explained the reason for the recall, along with the patient impact. Customers were to keep the letter as part of their laboratory records and also forward a copy to any other laboratories that they may have forwarded Total Bilirubin kits. U.S. Customers should contact Customer Service at 1-877-4ABBOTT, if they have questions.

Device

Device Recall Clinical Chemistry Total Bilirubin
  • 모델명 / 제조번호(시리얼번호)
    List Numbers: 6L45-20, 6L45-40 Lot Numbers: 64047HW00, 64048HW00, 65084HW00, 65088HW00, 69001HW00, 69002HW00, 72016HW00, 73038HW00, 73057HW00, 75036HW00, 76023HW00, 77014HW00, 69025HW00, 73015HW00, 76038HW00, 77015HW00.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Guatemala, Chile, Brazil, Canada, Germany, Hong Kong, Thailand, Puerto Rico, Australia, New Zealand, Trinidad & Tobago, Bermuda, Curacao, Cayman Island, and Jamaica.
  • 제품 설명
    Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. || Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates.
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

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