Events

Recall of Neogen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acumedia Manufacturers, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76053
  • Event Risk Class
    Class 2
  • Event Number
    Z-1093-2017
  • Event Initiated Date
    2016-04-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152054
  • Notes / Alerts
    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.
  • Extra notes in the data
    Culture media, non-selective and non-differential - Product Code JSG
  • Reason
    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.
  • Action
    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
  • Model / Serial
    7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Tryptic Soy Agar, Acumedia PN 7100 || 500g, 2Kg, 10Kg, and 50Kg sizes
  • Manufacturer
    Acumedia Manufacturers, Inc.

Manufacturer

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