VITROS® Automation Solutions configured with Thermo Scientific… — recall 61900
Health Canada — Medical Devices · Canada · 2020-12-11 · Type II
As described by Health Canada — Medical Devices: VITROS® Automation Solutions configured with Thermo Scientific Aliquoter & Labeller Module (2020-11-23)
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Reported risk: A software anomaly that has the potential to allow two secondary tubes from different primary samples to be labelled with the same sample IDs. Thermo Fisher Scientific has been unable to replicate the issue, as it requires a very specific set of events that must occur in a very specific time sequence. However, a contributing cause for this was that the Aliquoter Module was improperly initialized, as sample tubes were still in the module.
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