Health Canada — Medical Devices · Canada · 2018-04-06 · Type II
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Reported risk: When a reagent vial with an unreadable barcode is loaded on a reagents rack on IH-1000 (software version 04.07.02) and a test is performed, despite the fact the first reagent is correctly pipetted, the instrument will pipette in the vial with unreadable barcode for all the remaining wells.
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