Events

Recall of Blood Agar Plates, 5%, Lot 3155A.

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
    26681
  • Event Risk Class
    Class 3
  • Event Number
    Z-1076-03
  • Event Initiated Date
    2003-06-25
  • Event Date Posted
    2003-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28148
  • 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
  • Reason
    Customers complained of bacterial contamination of lot a10-3155a.
  • Action
    Firm conducted recall by telephone on June 25, 2003. Follow-up letter was sent within 2-3 business days. Customers were told to destroy inventory for credit or replacement.

Device

Blood Agar Plates, 5%, Lot 3155A.
  • Model / Serial
    Lot number A10-3155A.
  • Distribution
    Nationwide.
  • Product Description
    Blood Agar Plates, 5%, Lot 3155A.
  • Manufacturer
    Hardy Media Inc Dba Hardy Diag

Manufacturer

Hardy Media Inc Dba Hardy Diag
  • Manufacturer Address
    Hardy Media Inc Dba Hardy Diag, 1430 West McCoy Lane, Santa Maria CA 93455
  • Source
    USFDA