Events

Device Recall Triage TOX Drug Screen 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alere San Diego, 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
    63175
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0029-2013
  • 사례 시작날짜
    2009-05-28
  • 사례 출판 날짜
    2012-10-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112805
  • 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, methadone - Product Code DJR
  • 원인
    Biosite is recalling the triage tox drug screen kits where the box containing test devices because it was mislabeled.
  • 조치
    Biosite sent a Notice of Correction letter dated May 28, 2009 to all their customers who purchased the Triage TOX Drug Screen. The letter informed the customers of the problem identified and actions to be taken. Customers are instructed that performance of Triage TOX Drug Screen test devices is not affected in any way by the misprinted box flap, provided the test is used with a urine sample as per the instructions for use. Customers are instructed to complete and fax the enclosed verification form within 10 days. In the US, customers were instructed to contact Biosite at (877) 441-7440 or email productadvisory@invmed.com. Customers in UK are instructed to contact European Representative, Lesley Paice, lesley.paice@invmed.com.

Device

Device Recall Triage TOX Drug Screen
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: W42932B W42933B W42934B W42935B W43279B W43281B W43282B W43283B W43284B W43285B W43286B W43287B W43288B W43637B W43638B W43640B W43646B W43648B W43649B W43650B W43652B W43653B W43655B W43657B W43659B W43660B W43661B W43663B W43664B W43665B W43692B W43693B W43694B W43695B W43696B W43697B W43698B W43699B W43700B W43701B W43702B W43703B W43704B W43705B W43706B W43707B W43708B W43709B W43710B W43711B W43712B W43713B W43714B W43715B W43716B W43717B W43718B W43983B W43984B W43985B W43986B W43987B W43988B W43989B W43990B W43991B W43992B W43993B W43994B W43995B W43996B W43997B W43998B W43999B W44000B W44001B W44002B W44003B W44004B W44005B W44006B W44007B W44008B W44009B W44010B W44011B W44012B W44013B W44014B W44015B W44016B W44017B W44018B W44019B W44020B W44021B W44022B W44023B W44024B W44025B W44026B W44027B W44028B W44029B W44030B W44031B W44032B W44033B W44034B W44036B W44037B W44038B W44039B W44040B W44041B W44042B W44043B W44044B W44045B W44046B W44047B W44048B W44049B W44050B W44051B W44052B W44053B W44054B W44055B W44056B W44057B W44058B W44059B W44060B W44061B W44062B W44063B W44064B W44065B W44066B W44067B W44068B W44246B W44269B W44628B W44665B W44666B W44667B W44668B W44669B W44670B W44671B W44672B W44673B W44675B W44676B W44677B W44678B W44679B W44680B W44681B W44682B W44683B W44684B W44686B W44687B W44688B W44690B W44692B W44693B W44697B W44698B W44699B W44700B W44703B W44704B W44708B W44709B W44710B W44712B W44713B W44715B W44716B W44717B W44718B W44719B W44723B W44988B
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Finlind, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, India, Indonesia, Italy, Lebanon, Mexico, Netherlands, Norway, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, and Uruguay.
  • 제품 설명
    Triage TOX Drug Screen Panel, Model# 94400. || Product Usage: || The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • 제조사 주소
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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