WARNINGS AND PRECAUTIONS

• For In-Vitro Diagnostic Use.
• Do not use beyond labeled expiration date marked on the outer kit label. ? Do not interchange the caps with those of other reagent bottles.
• Dispose of containers and used contents in accordance with Federal, State, and Local requirements. 
• Use of Nitrile or Latex gloves is recommended when working with these controls.
• Follow proper hand washing hygiene after handling these controls.
• The External Controls are designed for use only with the QuickVue iFOB test.

STABILITY AND STORAGE

Store the QuickVue iFOB test Control Set at room temperature 59–86°F (15–30°C). Do not freeze. The contents can be used until the expiration date printed on the outer box, or four (4) weeks after the vials are opened, whichever occurs first.

QUALITY CONTROL

External controls may be used to demonstrate that all reagents and assays are performing properly. The QuickVue iFOB Control Set, when used in accordance with the test procedure described in the QuickVue iFOB test package insert, provide this capability.

TEST PROCEDURE

• All Test Cassettes and control reagent vials must be at room temperature before beginning the test.
• Remove the Test Cassette from the pouch and place it on a clean, flat, dry, level surface. ? Remove the control reagent vial screw cap by turning.
• Dispense six (6) drops of either the Positive or Negative control reagent into the Sample Well.
• READ RESULTS AT 5–10 MINUTES. Some positive results may be seen earlier. IMPORTANT: Do not read the test results after ten (10) minutes.