Events

Recall of Device Recall HardyCHROM 0157

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

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
    36309
  • Event Risk Class
    Class 3
  • Event Number
    Z-0078-2007
  • Event Initiated Date
    2006-08-21
  • Event Date Posted
    2006-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48393
  • 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
    E coli 0157 testing - Product Code GMZ
  • Reason
    Performance failure; the product is failing to show pigment development for e. coli 0157.
  • Action
    Customers were first notified by phone on 8/21/06. Then all customers are faxed and mailed a signed recall letter via first class mail. All customers will be contacted, calling every few days until all have responded and all product reconciliation is made. A second recall notice was mailed 09/25/06 to include the original lot (#06192) plus an additional lot (#06235). Customers will be instructed to dispose of all remaining inventory. Hardy Diagnostics will credit or replace their purchase.

Device

Device Recall HardyCHROM 0157
  • Model / Serial
    Lot numbers: 06192 (exp: 10/09/2006) and 06235 (exp:10/22/2006)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including the states of CA, IL, ME, NV, OK, TX, UT, WA & WY
  • Product Description
    HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455
  • Manufacturer
    Hardy Media Inc Dba Hardy Diag

Manufacturer

Hardy Media Inc Dba Hardy Diag
  • Manufacturer Address
    Hardy Media Inc Dba Hardy Diag, 1430 W Mccoy Ln, Santa Maria CA 93455-1005
  • Source
    USFDA