Events

MultiAnalyte Urine DAU Control (15 mL); 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
    60691
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0838-2012
  • 사례 시작날짜
    2011-08-05
  • 사례 출판 날짜
    2012-01-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106237
  • 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 mixture control materials - Product Code DIF
  • 원인
    Customer complaint investigation found that the multi-analyte urine dau level 2 control was incorrectly labeled and actually contained multi-analyte dau low level calibrators.
  • 조치
    Lin Zhi International, Inc. sent a Recall notification letter dated August 5, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to determine whether they wanted credit or a replacement product. The incorrectly labeled product should be disposed of properly. For questions regarding this recall call 408-732-3856.

Device

MultiAnalyte Urine DAU Control (15 mL);
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 0808, lot number 1101137, Exp 1/28/2013
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including MA, FL, NC, NH, WA, and IN.
  • 제품 설명
    Multi-Analyte Urine DAU Control (15 mL); || Level 2, For in-vitro diagnostic use only. || Lin-Zhi International, Inc. || 670 Almanor Ave. || Sunnyvale, CA 94085 || Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.
  • 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