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Endotoxin levels exceeded allowable limits.
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.