Events

ABX PENTRA Magnesium RTU 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
    69105
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2692-2014
  • 사례 시작날짜
    2014-08-11
  • 사례 출판 날짜
    2014-09-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129650
  • 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
    Photometric method, magnesium - Product Code JGJ
  • 원인
    Horiba medical is recalling the abx pentra magnesium rtu reagent because the on-board stability claims has been updated. horiba has updated the abx pentra magnesium rtu package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim.
  • 조치
    Horiba sent an Urgent Safety Notice letter dated August 11, 2014 to all customers running the Magnesium RTU assay on the ABX PENTRA 400 Chemistry analyzers that the On-Board Stability has been updated. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. For questions call 888-903-5001, ext 4266.

Device

ABX PENTRA Magnesium RTU
  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 || Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).
  • 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