During normal operation of the ortho vision analyzer, the camera imaging subsystem (CIMS) interfaces with a hardware camera to request and retrieve camera images for column grading and results interpretation. The camera software uses a first-in, first-out queuing system to take and return images to the CIMS software. Under an atypical software anomaly, images used for analysis of a test result did not come from the front and back sides of the same card. Ortho determined that the CIMS processed images out of synchronization (images captured earliest in sequence are placed at the top of the queue to be processed). As a result, image processing software utilized on the ortho vision analyzer may use mismatched front of card and back of card images for column grading and result interpretation. Recall start date: September 22, 2022
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