Events

Device Recall Alere Triage TOX Drug Screen 9 Panel 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
    63091
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2460-2012
  • 사례 시작날짜
    2012-07-12
  • 사례 출판 날짜
    2012-09-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112528
  • 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
    Colorimetry, acetaminophen - Product Code LDP
  • 원인
    Alere san diego is recalling alere triage tox drug screen because there is a possibility that after installing the code chip provided with the affected lots: amp, bar, and pcp, the threshold ranges may not be consistently set correctly in all meters.
  • 조치
    Alere sent a 'NOTICE OF CORRECTION" letter dated July 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers with questions were instructed to contact Technical Services at (877) 308-8287. Customers were instructed to complete the Customer/Distributor Verification Form Notice of Correction even if they do not have any involved product and fax back to Technical Services at (858) 805-8457 or scan and email to responses.ts@alere.com.

Device

Device Recall Alere Triage TOX Drug Screen 9 Panel
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: K51245RB, W51022RB, W51207RB
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. || The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the 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, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
  • 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