Events

Single Analyte Urine DAU Control (5 m L 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
    66542
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0386-2014
  • 사례 시작날짜
    2013-10-03
  • 사례 출판 날짜
    2013-11-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122570
  • 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
    Drug specific control materials - Product Code LAS
  • 원인
    Product catalog # a68825 norbuprenorphine 13 ng/ml level 2 controls gives a decreased concentration reading due to the degradation of the nbup analyte in solution.
  • 조치
    Beckman Coulter sent a Manufacturer Field Action Letter dated November 2013, to the one distributor. The letter identified the product the problem and the action needed to be taken by the customer. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. If you have any questions regarding this notice, please contact our Customer Support Center ¿¿ Via our website, http://www.beckmancoulter.com/customersupport/support ¿¿ Via phone, call 1-800-854-3633 in the United States ¿¿ Outside the United States, contact your local Beckman Coulter Representative. We apologize for any inconvenience.

Device

Single Analyte Urine DAU Control (5 m L
  • 모델명 / 제조번호(시리얼번호)
    Catalog #A68825, Lot #1307086; Exp. 3/28/2014/
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution in CA.
  • 제품 설명
    Single Analyte Urine DAU Control (5 m L || Norbuprenorphine, Level II control || For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. || Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. || Manufacturer: || Lin-Zhi International, Inc. || 670 Almanor Ave. || Sunnyvale, CA 94085 || The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
  • 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