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Vitros xt systems
Official notice
2 Aug 2022
Last checked
2 Aug 2022
An official Health Canada notice concerns 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 Published 2022-08-02.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64425
Official notice
2022-08-02
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Ortho-clinical Diagnostics, Vitros Xt.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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