Events

Device Recall EIA AntidsDNA Test 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
    56044
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1647-2011
  • 사례 시작날짜
    2010-03-02
  • 사례 출판 날짜
    2011-03-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92478
  • 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
    Anti-dna antibody (enzyme-labeled), antigen, control - Product Code LRM
  • 원인
    The firm received customer complaints of increased positivity rates associated with the anti-dsdna test kits.
  • 조치
    The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 2, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and quarantine the affected kit lots; discard all affected product in accordance with all local, state and federal disposal procedures; complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM via fax to: (510) 741-3954, attn: Bio-Rad CSD Regulatory Affairs Department, and to please re-evaluate all positive patient samples and retest if necessary. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.

Device

Device Recall EIA AntidsDNA Test Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 23191977, exp. 10/31/2010 23191979, exp. 10/31/2010 23191990, exp. 10/31/2010 23192172, exp. 10/31/2010 23192174, exp. 10/31/2010 23192175, exp. 12/31/2010 23192176, exp. 12/31/2010 23192490, exp. 2/28/2011 23100007, exp. 2/28/2011 23191837,
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including: Canada, Carribean, Chile, France, Germany, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and United Kingdom.
  • 제품 설명
    Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, || Catalog No. 96DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA || The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). For In Vitro Diagnostic Use.
  • 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