Events

Device Recall Clinical Chemistry Phenobarbital 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
    63945
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1118-2013
  • 사례 시작날짜
    2012-11-16
  • 사례 출판 날짜
    2013-04-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115089
  • 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
    Enzyme immunoassay, phenobarbital - Product Code DLZ
  • 원인
    Abbott diagnostics is recalling clinical chemistry phenobarbital reagent lots 62299un12 and 85773un12 due to imprecision issues which increase with the age of the reagent lot. the imprecision of the phenobarbital assay is d 7% total cv%; however, internal testing confirmed cvs up to approximately 12% for in-date reagent lots over five months old. although lot 52803un12 is now expired, it exhibit.
  • 조치
    Abbott Laboratories sent an Immediate Action Required Product Recall letter dated November 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures, order replacement lot 27426UN12 which will expire 18 DEC 2012, and is the only lot currently available (Additional lots will be available in December and January), and complete and return the enclosed Customer Reply Form. If lots were forwarded to another laboratory, a copy of the letter should be forwarded to them. For questions regarding this recall call 1-877-4ABBOTT. For customers outside of the US they should contact their local area Customers Service.

Device

Device Recall Clinical Chemistry Phenobarbital
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers 52803UN12, 62299UN12, and 85773UN12
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
  • 제품 설명
    Clinical Chemistry Phenobarbital, list number 1E08
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • 제조사 주소
    Abbott Laboratories, Inc, 1921 Hurd Dr, Irving TX 75038-4313
  • 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