The investigation determined that a higher than expected vitros tsh result was obtained for a patient sample when tested on a vitros 5600 integrated systems.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros tsh lot 5420 performance issue is not a likely contributor to the event.Analyzer performance is an unlikely contributor, however due to the delay between the event and the vitros tsh within-run precision test, an instrument issue cannot be completely ruled out.Improper pre-analytical sample handling may have contributed to this event as the customer is not following the sample collection device manufacturer¿s recommendation for sample centrifugation, although this cannot be confirmed.In addition, it is possible that an unknown patient sample interferent, could have contributed to the higher than expected result, although this could not be confirmed.
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