Events

Recall of Device Recall CHROMagar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DRG International 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
    53841
  • Event Risk Class
    Class 2
  • Event Number
    Z-1068-2010
  • Event Initiated Date
    2009-11-09
  • Event Date Posted
    2010-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86650
  • 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, antimicrobal susceptibility test, excluding mueller hinton agar - Product Code JSO
  • Reason
    Chromagar products are labeled incorrectly. label currently states that the product is for ivd use, when it should state that the product is intended for research use, not for use in diagnostic procedures.
  • Action
    Two recall letters were sent via certified mail to customers. One letter was dated November 9, 2009 referencing the CHROMagar VRE product and the other letter dated November 12, 2009 referencing the CHROMagar 0157 product. The letters describe the affected product, problem, and action to be taken by the customer. The customers are to please STOP the use or distribution of the listed products and IMMEDIATELY examine your stock and return any un-expired CHROMagar product slated for recall for replacement the DRG International, Inc. The customers are being requested to please fill out and return the disposition sheet even if you have none of these items on hand since the information is important. If you have any questions, please contact customer service at (908) 233-0758.

Device

Device Recall CHROMagar
  • Model / Serial
    Catalog numbers EE220, EE222, all lots within expiry.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    CHROMagar 0157; || 5000 ml (29.2 g/L) || EE222; IVD || For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. || Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.
  • Manufacturer
    DRG International Inc

Manufacturer

DRG International Inc
  • Manufacturer Address
    DRG International Inc, 1167 US Highway 22, Mountainside NJ 07092-2807
  • Manufacturer Parent Company (2017)
    Drg International Inc
  • Source
    USFDA