When conflicting results occur within a test run, firms should consult USP Chapter <85>, Gel Clot Limits Test, Interpretation, for guidance on repeat testing. As specified in Chapter <85>, if the test failure occurred at less than the maximum valid dilution (MVD), the test should be repeated using a greater dilution not exceeding the MVD. A record of this failure should be included in the laboratory results. If a test is performed at the MVD and an out-of-specification (OOS) test result occurs that cannot be attributed to testing error, the lot should be rejected.
