Events

Device Recall ToxCup Drug Screen Cup 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Branan Medical Corporation 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
    67818
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1508-2014
  • 사례 시작날짜
    2014-03-26
  • 사례 출판 날짜
    2014-04-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-07-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126393
  • 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, cocaine and cocaine metabolites - Product Code DIO
  • 원인
    May be labeled with incorrect result interpretation graphics on the toxcup lid label.
  • 조치
    The firm, Branan Medical Corp (BMC), sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 26, 2014 to all the customers who received the ToxCup Drug Screen Cup. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of product; quarantine all units of these product lots; destroy unused product(s) in compliance with your laboratory and state requirements; share this information with your staff and retain notification as part of your QS documentation; if distributed to your customers, provide a copy of this letter to them; complete and return the enclosed Customer Verification Form via Fax to: Branan Medical Corporation at 949-598-7167 or by e-mail at: branan.complaints@brananmedical.com within 10 days. Should you have any questions about the information contained in this notification, contact Branan Medical Corporation at (949) 598-7166 or email branan.complaints@brananmedical.com.

Device

Device Recall ToxCup Drug Screen Cup
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and country of Canada.
  • 제품 설명
    ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.
  • Manufacturer
    Branan Medical Corporation

Manufacturer

Branan Medical Corporation
  • 제조사 주소
    Branan Medical Corporation, 140 Technology Dr Ste 400, Irvine CA 92618-2426
  • 제조사 모회사 (2017)
    Branan Medical Corporation
  • Source
    USFDA