Health Canada — Medical Devices · Canada · 2023-11-24 · Type II
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Reported risk: Ortho Cinical Diagnostics (quidelortho) has determined that some lots from coating 3598 of Vitros Eco2 Slides include carts which may contain consecutive slides that may not function as intended. These affected Vitros Eco2 slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positively or negatively biased results. Due to the nature of the abnormality, which can vary across the affected slides, the magnitude of potential bias can vary from slide to slide. Recall start date: October 26, 2023
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