Vitros Xt Systems

Ortho Clinical Diagnostics (Ortho) became aware of an anomaly that affects Vitros Xt 3400 and Vitros Xt 7600 systems. These systems utilize a digital imaging reflectometer and led light source to generate Vitros microslide assay results. Ortho's on-going investigation has determined that performing a system shutdown on Vitros Xt 3400 and Vitros Xt 7600 systems may, in some instances, cause a positive or negative shift in the electrical current supplied to the led used in conjunction with the digital imaging reflectometer. This shift in electrical current may also lead to a shift in multiple Vitros microslide assay results reported by the system.

Recall start date: July 22, 2022