Events

BINDAZYME 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Inova Diagnostics Incorporated 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
    55801
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1942-2010
  • 사례 시작날짜
    2009-10-28
  • 사례 출판 날짜
    2010-06-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-06-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91848
  • 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
    in vitro diagnostic - Product Code DAK
  • 원인
    The recall was initiated after the binding site notified inova diagnostics, inc. that the affected bindazyme human c1q binding circulating immune complex eia kits may contain an elisa plate labeled as "tissue transglutaminase coated wells" instead of "c1q coated wells".
  • 조치
    Notification letters from INOVA Diagnostics Incorporated were mailed to each of the consignees via Certified mail on October 30, 2009. The notification letters inform the consignees of the reason for recall and provided instructions for final disposition of the recalled kits. In addition, a FAX back Attachment was attached to the recall notice for customers to respond to the recall.

Device

BINDAZYME
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 273005A, 273005B, 273005C, and 273005D
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, and India.
  • 제품 설명
    Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • 제조사 주소
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA