The investigation determined the higher than expected vitros glu results were obtained for multiple quality control fluids and patient samples run on a vitros 5600 integrated system.The assignable cause of the event is unknown, however, the most likely assignable cause is a non-reactive cartridge caused by having the integrity of the foil wrapper compromised and exposing the slides to ambient conditions, although this could not be confirmed.For the vitros glu assay, a non-reactive cartridge causes higher than expected results.Acceptable glu results were obtained when the same samples were tested with an alternate vitros glu slide lot 0030-0918-2862 cartridge, and quality control results processed on alternate vitros glu slide lot 0030-0918-2862 cartridges prior to, and after the event were acceptable.This would indicate the event was isolated to the affected vitros glu slide lot 0030-0918-2862 cartridge in use at the time of the event.
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