Events

Device Recall Human Alpha1Antitrypsin Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 The Binding Site Group, Ltd. 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
    78047
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0002-2018
  • 사례 시작날짜
    2017-08-23
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158557
  • 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
    Alpha-1-antitrypsin, antigen, antiserum, control - Product Code DEM
  • 원인
    The high control for the kit is recovering low and may be out of range for assigned values.
  • 조치
    Binding Site sent an Field Safety Notice dated August 24, 2017, explaining the reason for recall and requesting the direct account and their customer to remove the affected kits from inventory and dispose of them. The direct account and their customers were instructed to circulate the field safety notice to other persons who use the product within their organization. A response form, to be returned via email, was enclosed for completion to indicate the number of kits discarded. For further questions, please call (858) 453-9177.

Device

Device Recall Human Alpha1Antitrypsin Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot #400900, Exp. 12/31/2017, UDI #05051700016421
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.
  • 제품 설명
    Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. || Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
  • Manufacturer
    The Binding Site Group, Ltd.

Manufacturer

The Binding Site Group, Ltd.
  • 제조사 주소
    The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
  • 제조사 모회사 (2017)
    Cidron Iugo Sarl
  • Source
    USFDA