Events

Recall of Device Recall HardyCHROM MRSA

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
    71804
  • Event Risk Class
    Class 2
  • Event Number
    Z-2463-2015
  • Event Initiated Date
    2015-07-09
  • Event Date Posted
    2015-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139127
  • 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 mrsa due to a report of the potential for breakthrough of the methicillin-sensitive staphylococcus aureus (mssa) qc strain, atcc 29213 on the identified lot.
  • Action
    The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1. Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.

Device

Device Recall HardyCHROM MRSA
  • Model / Serial
    Cat no. G307 Lot no. H15155
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
  • Product Description
    HardyCHROM MRSA || Cat no: G307 Lot no: H15155 || Expires: 2015-08-13 || Container Type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage: 2-8C on receipt. Light Sensitive. || In vitro diagnostic || www.HardyDiagnostics.com
  • 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