Health Canada — Medical Devices · Canada · 2019-07-26 · Type II
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Reported risk: An incident occurred on architect instrument for intermittent false high Lithium results, the cause has been identified in the carryover of LDH reagent 1 which contains Lithium when the test is performed on a sub-optimal performing instrument. To prevent occurrence of such an event, and as a preventive protection of patient health, an additional smartwash step is recommended for the Lithium assay. A field action is required in order to advise end users to add this additional step.
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