Events

Acumedia Urea Base Agar 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Acumedia Manufacturers, 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
    77276
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2221-2017
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155596
  • 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
    Culture media, selective and differential - Product Code JSI
  • 원인
    Storage temperature listed on the label was incorrect. label stated 2-30¿c. actual storage temperature is 2-8¿c.
  • 조치
    Neogen Corporation sent a Product Notification dated September 25, 2016, to all affected consignees via email. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product. Consignees were informed that an internal corrective action has been initiated and actions have been taken and implemented to prevent this situation from occurring again. The label has been corrected and existing inventory has been relabeled. For questions regarding this recall call 800-234-5333, ext 2362.

Device

Acumedia Urea Base Agar
  • 모델명 / 제조번호(시리얼번호)
    PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
  • 제품 설명
    Urea Base Agar, Acumedia PN 7226 || Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
  • Manufacturer
    Acumedia Manufacturers, Inc.

Manufacturer

Acumedia Manufacturers, Inc.
  • 제조사 주소
    Acumedia Manufacturers, Inc., 740 E Shiawassee St, Lansing MI 48912-1218
  • Source
    USFDA