PROBLEM REPORTING

Any problems encountered using a product obtained from Hardy Diagnostics should be reported immediately. The user should be prepared to state:

  1. the product name and number
  2. lot number
  3. date and time it was received
  4. temperature at which it was stored
  5. the percentage of units affected

A careful, documented investigation will then be conducted, followed by notification of results to the user.

Experience has shown that most problems are due to the following three situations:

  1. Damage in Transit
    This can be due to improper or rough handling of media during shipment.
  2. Exposure to Heat
    Excessive exposure to heat will cause productscontaining blood to become hemolyzed producing a browning or "root beer" effect. It will also lead to excessive moisture accumulation in the bag of plated media, ultimately resulting in contamination. This can happen either in transit or by not refrigerating plated media immediately upon arrival.
  3. Exposure to Freezing Temperatures
    Any exposure to freezing temperatures, even if for a short duration, will cause a softening of the media, excessive surface moisture, and a rough surface texture. Refrigerator temperatures must be carefully monitored each day. The proper storage temperature for plated media is 2 to 8 degrees C (35.6 to 46.4 degrees Fahrenheit). It is safest to set the temperature of the refrigerator at 6 degrees C.(20)
    Please note that even a refrigerator that is set at the proper temperature can still freeze the media if it is stored too close to the freezer compartment! Also remember that a refrigerator that is set at the proper temperature may cycle a few degrees lower at times and expose the media to dangerously low temperatures! In addition, the temperature of the refrigerator may have to be monitored at several locations within the compartment, due to "cold or warm spots" that may occur. For more information see the keyword "Storage."

The user laboratory is required to document and report to the manufacturer any defects along with corrective action taken in accordance with the CAP, CLSI (formerly NCCLS), and California Department of Health requirements.(7,13,14)

TECHNICAL SERVICES AND INFORMATION

Further product technical information on each product is available within this HUGO™ program.

There are licensed Medical Technologists and microbiologists on staff for customer assistance. Technical Service can be obtained by calling (800) 266-2222 extension 5658.

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