Events

MultiAnalyte Urine DAU Intermediate Calibrator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Lin-Zhi International 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
    60757
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0847-2012
  • 사례 시작날짜
    2011-10-11
  • 사례 출판 날짜
    2012-01-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106403
  • 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
    Calibrators, drug mixture - Product Code DKB
  • 원인
    Catalog # 0804 multi-analyte urine dau intermediate calibrators were incorrectly labeled and mistakenly filled with catalog # 0805 dau high calibrators.
  • 조치
    Lin -Zhi International sent a Recall letter dated October 11, 2011, and a e-mail to all affected customers. This was followed up by a personal phone call from Lin-Zhi personnel. The letter identified the product the problem and the action needed to be taken by the customer. The customer will be contacted to determine whether or not they were affected by this non-conformity. If they have been affected, they will be offered replacement Multi-Analyte Urine Intermediate Calibrators which are currently estimated to have a four week wait time before they become available. For further questions please call (408) 732-3856.

Device

MultiAnalyte Urine DAU Intermediate Calibrator
  • 모델명 / 제조번호(시리얼번호)
    Catalog 0804; lot number 1101138K2, exp 1/28/2013
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of NC,MA, NH and TX. and the country of Germany,
  • 제품 설명
    Multi-Analyte Urine DAU Calibrator (15 mL); || Multi-Analyte,Intermediate Calibrator; || for in-vitro diagnostic use only. || Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. || Drug abuse testing || Lin-Zhi International, Inc.' || 670 Almanor Ave. || Sunnyvale, CA 94085.
  • Manufacturer
    Lin-Zhi International Inc

Manufacturer

Lin-Zhi International Inc
  • 제조사 주소
    Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
  • 제조사 모회사 (2017)
    Lin-Zhi International Inc.
  • Source
    USFDA