Events

Device Recall Histoplasma Yeast Complement Fixation Antigen Dilute 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Immuno-Mycologics, 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
    74113
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2040-2016
  • 사례 시작날짜
    2016-05-09
  • 사례 출판 날짜
    2016-06-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146320
  • 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
    Antigens, histoplasma capsulatum, all - Product Code GMJ
  • 원인
    The device was found to have bacterial contamination.
  • 조치
    Immuno-Mycologics, Inc sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their stock and destroy affected stock on hand. Immediately complete the attached Acknowledgement and Receipt Form even if they do not have affected stock. Customers who require replacement indicate the number of vials needed in the attached Acknowledgement Form. Customers with questions were instructed to call 1-405-360-4669.

Device

Device Recall Histoplasma Yeast Complement Fixation Antigen Dilute
  • 모델명 / 제조번호(시리얼번호)
    Lot 111WH3
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
  • 제품 설명
    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 || The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
  • Manufacturer
    Immuno-Mycologics, Inc

Manufacturer

Immuno-Mycologics, Inc
  • 제조사 주소
    Immuno-Mycologics, Inc, 2700 Technology Pl, Norman OK 73071-1127
  • 제조사 모회사 (2017)
    Immuno-Mycologics Inc.
  • Source
    USFDA