Ortho Optix™ Reader

Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in table below), without the site having processed the multiple QC kits configured for the test. Ortho confirmed that any test processed with multiple QC kits may encounter this issue. If one QC kit out of the multiple QC kits configured for the test has successfully passed, the software will automatically assign a passing QC status to the test even if the other QC kit configured for the test is not run or does not pass.

Recall start date: Apr 11, 2022