Product Wiki · Recalls · Health Canada — Medical Devices

Vitros Xt Systems — recall 64425

Health Canada — Medical Devices · Canada · 2022-08-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64425
Date of alert
2022-08-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-xt-systems

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