Events

Device Recall Autoimmune EIA ANA Screening Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bio-Rad Laboratories 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
    56385
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1479-2011
  • 사례 시작날짜
    2010-03-01
  • 사례 출판 날짜
    2011-03-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93344
  • 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
    Antinuclear Antibody, Antigen Control - Product Code LKJ
  • 원인
    The firm received customer complaints of increased positivity rates associated with the ana screening kit due to a decline in stability.
  • 조치
    An Urgent: Medical Device Recall Notification, dated March 1, 2010, was provided to the firm's consignee, identifying the affected product and stating the reason for the recall. The letter also asked the customer to examine their inventory and quarantine the affected kits. If the product had been further distributed, those customers must be identified, notified, and asked to discontinue use of the affected product. Customers were to discard all affected product and complete and return the enclosed Medical Device Recall Response Form. The letter also stated that replacement kits would be available in mid-March.

Device

Device Recall Autoimmune EIA ANA Screening Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 24591524, exp 10/31/2010; 24591936, exp 12/31/2010; and 24500022, exp 12/31/2010.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- New York, US.
  • 제품 설명
    Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, || Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. || Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • 제조사 주소
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA