Events

Recall of Nitrate Reagent A, Cat No. Z71, Lot 3338 || Nitrate Reagent B, Cat No. A72, Lot 3338

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
    28120
  • Event Risk Class
    Class 3
  • Event Number
    Z-0542-04
  • Event Initiated Date
    2003-12-31
  • Event Date Posted
    2004-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31238
  • 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
    Discs, Strips And Reagents, Microorganism Differentiation - Product Code JTO
  • Reason
    Mislabeled.
  • Action
    Customers were first notified by telephone on 12/31/2003. Then customers are mailed a sigh\ned recall letter via first class mail. All customers will be contacted by telephone to reconcile returns.

Device

Nitrate Reagent A, Cat No. Z71, Lot 3338 || Nitrate Reagent B, Cat No. A72, Lot 3338

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