Events

Device Recall Dropper Plus PointofCare Urinalysis Dipstick Control kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Quantimetrix 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
    80179
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2257-2018
  • 사례 시작날짜
    2017-12-21
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164785
  • 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
    Urinalysis controls (assayed and unassayed) - Product Code JJW
  • 원인
    The kits contained an incorrect lot of dropper plus level 1 vials.
  • 조치
    Communication with their only customer for this recall was via e-mail and phone. Upon notification by the customer the following activities were initiated: All lots of the Dropper Plus product in inventory were 100% inspected. The customer was ask to return all of the kits to Quantimetrix. For further questions please call (310) 536-0006.

Device

Device Recall Dropper Plus PointofCare Urinalysis Dipstick Control kit
  • 모델명 / 제조번호(시리얼번호)
    Lot 44450E
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to the state of : Kansas
  • 제품 설명
    Dropper Plus Point-of-Care Urinalysis Dipstick Control kit || The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
  • Manufacturer
    Quantimetrix Corporation

Manufacturer

Quantimetrix Corporation
  • 제조사 주소
    Quantimetrix Corporation, 2005 Manhattan Beach Blvd, Redondo Beach CA 90278-1205
  • 제조사 모회사 (2017)
    Quantimetrix Corporation
  • Source
    USFDA