Events

Device Recall DrugCheck Drugs of Abuse Ketamine Dip Test 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Express Diagnostics Int'l., 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
    70008
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1033-2015
  • 사례 시작날짜
    2014-11-21
  • 사례 출판 날짜
    2015-01-30
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132104
  • 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
    Test system, for drugs of abuse - Product Code MGX
  • 원인
    This recall has been initiated due to potential false positives results when using the test to screen for ketamine. use of this product may give incorrect screening results.
  • 조치
    Consignees were sent an Express Diagnostic Int. Inc., "Urgent" Letter dated 11//21/2014. The letter described the problem and the product involved in the recall. It advised consignees to quarantine the product. If the product has been further distributed, consignees were advised to notify their customers at once, Consignees were requested to complete and return the "Acknowledgement Form" either via fax to 1-507-526-2252 or e-mail Quality@drugcheck.com. For questions consignees can contact Jackie Gale, Director of Quality Systems and Regulatory Affairs at 1-507-526-3951.

Device

Device Recall DrugCheck Drugs of Abuse Ketamine Dip Test
  • 모델명 / 제조번호(시리얼번호)
    PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.
  • 제품 설명
    DrugCheck Ketamine Dip Test || 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. || This assay provides only a preliminary analytical test result.
  • Manufacturer
    Express Diagnostics Int'l., Inc.

Manufacturer

Express Diagnostics Int'l., Inc.
  • 제조사 주소
    Express Diagnostics Int'l., Inc., 1550 Industrial Dr, Blue Earth MN 56013-1100
  • 제조사 모회사 (2017)
    Express Diagnostics Intl Inc.
  • Source
    USFDA