Events

Device Recall ADVIA Chemistry Systems Acetaminophen Nacetylcysteine (NAC) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, 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
    71710
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2416-2015
  • 사례 시작날짜
    2015-06-30
  • 사례 출판 날짜
    2015-08-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-09-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138801
  • 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
    Colorimetry, acetaminophen - Product Code LDP
  • 원인
    A change in the concentration of n-acetylcysteine (nac) that may cause interference for the advia¿ chemistry systems acetaminophen assay for certain lots.
  • 조치
    Siemens sent an Urgent Medical Device Correction letter dated June 30, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. Siemens Healthcare Diagnostics is conducting a voluntary recall for the ADVIA Chemistry Acetaminophen reagent, for all in date and future kit lots. Customers were informed of the revised interference levels of N-acetyl cysteine (NAC) of 200 mg/dL, for the ADVIA Chemistry Acetaminophen assay. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For further questions call 1 (800) 441-9250.

Device

Device Recall ADVIA Chemistry Systems Acetaminophen Nacetylcysteine (NAC)
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 07989138, Siemens Material Number (SMN) 10327381, Lot Numbers: 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157, 47558; with expiration dates June 30, 2015 through April 30, 2016.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and to the countries of : Canada, Netherlands, Great Britain, Norway, Sweden, Spain, Italy, Germany, France, Finland, Belgium, Portugal, Czech Republic, Israel, Poland, Turkey and Bahrain.
  • 제품 설명
    ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA