Events

Recall of Device Recall HardyCHROM VRE Agar

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

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
    71577
  • Event Risk Class
    Class 2
  • Event Number
    Z-2192-2015
  • Event Initiated Date
    2015-06-24
  • Event Date Posted
    2015-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138251
  • 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, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
  • Reason
    Hardy diagnostics is recalling hardychrom vre agar due to lack of 510(k) clearance.
  • Action
    The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinuing the product and as part of the process were recalling anything that still might be within expiration date. The phone script stated that the firm was going to be sending something in writing. On 06/24/15 the firm sent out a notification letters to customers to inform them that they were discontinuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the enclosed form stating their compliance with the above action. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at TechService@HardyDiagnostics.com.

Device

Device Recall HardyCHROM VRE Agar
  • Model / Serial
    Cat No.: G333 Lot No.: H15055
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to one U.S. customer in SC.
  • Product Description
    HardyCHROM VRE Agar-RSR || Cat no: GA333 Lot no: H15055 || Expires: 2015-07-04 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage 2 to 8 degrees C on receipt || Chromogenic medium for stool pathogen screening.
  • Manufacturer
    Hardy Diagnostics

Manufacturer

Hardy Diagnostics
  • Manufacturer Address
    Hardy Diagnostics, 1430 W Mccoy Ln, Santa Maria CA 93455-1005
  • Manufacturer Parent Company (2017)
    Hardy Diagnostics
  • Source
    USFDA