An end user site attempted to perform QC on a single test using multiple QC kits. The QC module was not designed to support testing of multiple QC kits for a single test, and it is required that all QC samples used to validate a test are contained in a single QC kit in Ortho Connect™. If a test is processed across multiple QC kits, the QC status will be based on the results of only a single QC kit - if a single QC kit has a passing QC status, the status will be considered as passing for the test. This is the same failure mode that was previously communicated for Optix Reader regarding the quality control (QC) status displayed when using multiple QC kits. Recall start date: May 4, 2022
RecallTracker