Product Manual

Page 9 of 41
Potential Biohazard!
To reduce the risk of biohazard:
 Dispose of used specimens in accordance with Federal, State and Local requirements.
 Treat specimens and patient samples as potentially biohazardous material.
 Ensure Sofia 2 is cleaned per the Maintenance and Cleaning section.
 Seek specific training or guidance if you are not experienced with specimen collection and
handling procedures.
 Use of Nitrile, Latex, or other gloves is recommended when handling patient samples.
Caution!
To reduce the risk of incorrect results:
 Sofia 2 should only be used by trained operators.
 Do not use if Sofia 2 is reporting an error condition that cannot be corrected.
 To obtain accurate results, refer to the assay-specific Package Insert for details on specific
tests.
 Use the test kit within the expiration date.
To reduce the risk of Sofia 2 damage:
 Sofia 2 is designed for counter top operation.
 Sofia 2 is not designed to withstand moisture, extreme humidity, or extreme
temperatures.
 Sofia 2 is not designed to withstand severe shock or vibration.
 Do not open or disassemble the device.
Failure to follow the precautions mentioned above will invalidate the warranty.
To reduce the risk of environmental contamination:
 Contact Quidel Technical Support at 800.874.1517 for return or disposal of Sofia 2. See
page 3 for additional contact information.
 Clean Sofia 2 per the Maintenance and Cleaning section of this User Manual prior to
return or disposal.
 Sofia 2 must be disposed of in a safe and compliant manner. Applicable Federal, State and
Local regulatory requirements shall be followed to ensure Sofia 2 is not disposed of as
municipal waste. If you are unsure on the proper methods for disposal, contact a certified
waste broker for guidance.
Note: Medical equipment that may have come into contact with potentially infectious materials
(e.g., patient samples, blood, serum, etc.) must be properly decontaminated prior to disposal or
recycling.