Events

Neogen 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
    76053
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1093-2017
  • 사례 시작날짜
    2016-04-22
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152054
  • 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, non-selective and non-differential - Product Code JSG
  • 원인
    Light precipitate may form in prepared plates of acumedia tryptic soy agar (7100) lot# 108166. while there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.
  • 조치
    Neogen sent a Recall Notification dated March 8, 2016, to all affected customers on April 22, 2016. via e-mail. The recall notification included a description of the reason for the recall, affected product, and offer for replacement. If any Tryptic Soy Agar from this lot remains in your inventory, and you would like to replace this lot, please contact the customer service team at Neogen Corporation by email at foodsafety@neogen.com or by telephone at (800)-234-5333. We would like to assure you that we are committed to providing products that meet our strict quality standards for your testing needs. Neogen will investigate this isolated incident to determine the root cause and implement measures to ensure that this issue does not happen in the future.

Device

Neogen
  • 모델명 / 제조번호(시리얼번호)
    7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TX, TN, UT, VA, WI. and to the countries of : CANADA, UK, ISRAEL, MEXICO, AUSTRALIA, COLOMBIA, TAIWAN, BRAZIL, CHILE and INDONESIA.
  • 제품 설명
    Tryptic Soy Agar, Acumedia PN 7100 || 500g, 2Kg, 10Kg, and 50Kg sizes
  • Manufacturer
    Acumedia Manufacturers, Inc.

Manufacturer

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