Ortho Optix™ Reader — recall 72209

Reported risk: Ortho confirmed when multiple orders are processed for the same patient on the Ortho Optix™ Reader, the software may not be able to identify the orders are for the same patient and may not perform the discrepant result checks in 4 different scenarios listed below. Scenario 1: 1. an lis order record containing 'attending physician' data (field p14) is imported. 2. a manual order is created for the same patient without any modifications to patient demographics (using patient search). 3. the orders are processed to completion. in this scenario, the 'attending physician' information is not included in the manual order. the software detects the manual order as a different version of the patient than the lis order (containing the 'attending physician' data) and the discrepant result check is not performed. Scenario 2: 1. a manual order is created. an lis order is created for the same patient containing 'attending physician' data. if these steps occur, the software detects the lis order (containing the 'attending physician' data) as a different version of the patient than the manual order and the discrepant result check is not performed. Scenario 3: 1. an order is created by either importing an lis order or creating a manual order for a new patient. a manual order is created for the same patient (using patient search) and the patient demographic is modified (for example first name, last name, birthdate, or national id). Recall start date: November 10, 2022