Events

Device Recall ABX PENTRA Urine Control L/H 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Horiba Instruments, Inc dba Horiba Medical 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
    67133
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0924-2014
  • 사례 시작날짜
    2013-12-18
  • 사례 출판 날짜
    2014-02-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124753
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • 원인
    Horiba medical is informing all abx pentra urine control l/h customers running the creatinine assay on abx pentra chemistry analyzers that the target range for creatinine has been updated. the abx pentra urine control l/h lot specific annexes have been updated to include revised acceptable target ranges for creatinine.No other analyte values are affected.
  • 조치
    HORIBA Medical sent an Urgent Safety Notice dated December 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to update their Quality Control procedures to include the new Creatinine Target Ranges for the ABX PENTRA Urine Control L/H Reference #: A11A01674 and Lot #s: 1207001, 1303601, and 1300701. Customers were instructed to complete and return the enclosed response form to verify their understanding of the Field Safety Notice. Customers with questions were instructed to contact their local HORIBA Medical representative. For questions regarding this recall call 949-453-0500.

Device

Device Recall ABX PENTRA Urine Control L/H
  • 모델명 / 제조번호(시리얼번호)
    Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Canada.
  • 제품 설명
    ABX PENTRA Urine Control L/H. || The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control || consisting of liquid solutions prepared from human urine with chemical additives and || materials of biological origin added as required to obtain given component levels. The || assigned values of the control components are given in the labeling, ensuring control of || the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. || Each control level is provided in one vial of 10 ml. || The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical

Manufacturer

Horiba Instruments, Inc dba Horiba Medical
  • 제조사 주소
    Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
  • 제조사 모회사 (2017)
    Horiba Ltd.
  • Source
    USFDA