Events

Device Recall VisuaLine Tricyclic Antidepressants 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sun Biomedical 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
    48464
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1875-2008
  • 사례 시작날짜
    2008-05-28
  • 사례 출판 날짜
    2008-09-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-06-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71480
  • 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
    Methadone enzyme immunoassay - Product Code DJR
  • 원인
    Product was sold while the devices were under fda 510 (k) review, which was subsequently denied.
  • 조치
    On May 29, 2008, Recall Notification Letters were sent via UPS Ground. Each letter had a red label reading "Market Withdrawal Notification on the envelope. Use of the product and distribution was to stop immediately. Returns to be made by UPS and replacement or refund to be issues. If you have any questions contact Jenny Shelton, Sun Biomedical, at 1-888-440-8388.

Device

Device Recall VisuaLine Tricyclic Antidepressants
  • 모델명 / 제조번호(시리얼번호)
    Sun Biomedical Part 15-2043; Lot Vis-6SP-Dip 08-021-1; Part 15-2046; lot Vis-6SP-Dip 07-270-1; Part 15-2065, lot Vis-8SP-Dip-07-207-2; Part 15-2072, lot Vis-9SP-Dip-07-106-1; Part 15-2080, lot Vis-10 Dip 06-204-2, Vis-10 Dip 07-002-2, Vis-10-Dip-07-231-1; Part 15-2083, lot Vis-10SP-Dip-07-311-1; Vis-10SP-Dip 07-324-1, VIS 10SP-Dip-08-045-3; Part 15-2085, Lot Vis 10SP Dip-07-201-1, Vis-10SP-Dip 07-263-1; Part 15-2095, lot Vis 5SP-Dip 07-284-2; Vis 5SP-Dip -8-008-01; and Part 15-2101, lot Vis-6SP Dip-07-326-1.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
  • 제품 설명
    VisuaLine Tricyclic Antidepressants: || Six Dip (COC-THC-OPI-MET-BZD-OXD); || Six Dip (COC-THC-OPI-MET-PCP-OXD); || Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); || Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); || Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); || Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); || Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); || Five Dip (COC-THC-OPI-BZD-OXD); and || Six Dip (CPC-THC-OPI-MET-AMP-OXD). || Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
  • Manufacturer
    Sun Biomedical Laboratories, Inc.

Manufacturer

Sun Biomedical Laboratories, Inc.
  • 제조사 주소
    Sun Biomedical Laboratories, Inc., 1001 Lower Landing Rd, Blackwood NJ 08012-3124
  • Source
    USFDA