Health Canada — Medical Devices · Canada · 2024-03-07 · Type II
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Reported risk: Some serial numbers of the Vitros® systems as listed above may experience an anomaly involving the sampling center, which may have been manufactured using a sub-optimal hardware part. Quidelortho confirmed a complaint where the sampling center mechanism unintentionally disengaged from the universal sample tray (tray), resulting in the misalignment of the intended sample container to be aspirated. From our investigation of this single occurrence, Quidelortho determined that if this disengagement and misalignment occurs, it may cause one or multiple patient samples to be aspirated from an unintended sample container within the same tray and report the results using the incorrect patient samples. Based on the investigation, Quidelortho estimates the likelihood of this occurrence to be approximately 0.00000035% (or about 1 in 2.88 million tests.) Recall start date: January 26, 2024
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