Device Recall ABX PENTRA Lactic Acid CPref. A11A01721 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Horiba Instruments 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
    73033
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0741-2016
  • 사례 시작날짜
    2016-01-11
  • 사례 출판 날짜
    2016-02-02
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-06-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Acid, lactic, enzymatic method - Product Code KHP
  • 원인
    N-acetylcysteine (nac) present in the blood of patients treated for paracetamol overdose can interfere with the trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the trinder reaction method.
  • 조치
    Customer notification letters were sent on 01/11/16. Customers were provided the following instructions/actions: When performing tests that use the Tinder reaction, the blood draw should be done before treatment is given to the patient. Reagent inserts for the concerned HORIBA Medical Products have been updated and now include the following additional warning: Patients treated with N-Acetylcysteine (NAC) for Paracetamol overdose may generate a false low result. The letter request customers share the information with laboratory staff and retain the notification as part of their laboratory documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days in order for the firm to verify the understanding of the notice. If any questions contact the local HORIBA Medical representative.

Device

  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
  • 제품 설명
    ABX PENTRA Lactic Acid CP ref. A11A01721 || reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
  • Manufacturer

Manufacturer

  • 제조사 주소
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • 제조사 모회사 (2017)
  • Source
    USFDA