Events

Magnesium on RX Imola analyser 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Randox Laboratories, Limited 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
    75263
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0725-2017
  • 사례 시작날짜
    2016-04-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149845
  • 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
    According to the firm, carry over was observed when the amylase or pancreatic amylase test is run directly before or after the magnesium assay. an update is required to the rx imola analyser running order and an acid wash recommended when setting up the magnesium assay. a correction was made to the ifu for the magnesium assay and all rx imola customers in the usa were contacted with the updated instruction.
  • 조치
    Randox sent an Urgent Field Safety Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review and update Rx Imola running order where required. Rework any remaining stock with updated IFU and Important Notice. Complete and return the vigilance response section of the form to technicalservikces@randox.com.

Device

Magnesium on RX Imola analyser

Manufacturer

Randox Laboratories, Limited
  • 제조사 주소
    Randox Laboratories, Limited, Ardmore 55 The Diamond Road, Crumlin United Kingdom
  • 제조사 모회사 (2017)
    Randox Holdings Limited
  • Source
    USFDA