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Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.
Product does not meet performance specifications through its labeled expiration period.
Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2).