Health Canada — Medical Devices · Canada · 2019-04-18 · Type II
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Reported risk: Worn out or leaking centrifuge tubes due to a multifaceted set of events involving the CATSmart systems (device, software and disposable) which may result in the centrifuge tubing line making contact with the washing chamber thereby causing excessive wear on the centrifuge tubing or in extreme cases a puncture of the tubing. 1) The centrifuge tubing line being within specification but not at its nominal length and/or 2) combined with priming acceleration parameters of the CATSmart device.
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