Events

Recall of Acumedia Urea Base Agar

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
    77276
  • Event Risk Class
    Class 3
  • Event Number
    Z-2221-2017
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155596
  • 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, selective and differential - Product Code JSI
  • Reason
    Storage temperature listed on the label was incorrect. label stated 2-30¿c. actual storage temperature is 2-8¿c.
  • Action
    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
  • Model / Serial
    PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
  • Product Description
    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.
  • Manufacturer Address
    Acumedia Manufacturers, Inc., 740 E Shiawassee St, Lansing MI 48912-1218
  • Source
    USFDA