On (b)(6) 2015 a customer reported low total area (ta) with their calibrators when run on their g8 analyzer.The customer made fresh calibrators with the same lot and still got low tas.The customer then under diluted the calibrators by 25%, this allowed the calibrators to run but only with tas of 666 and 603; still low but passable.The customer was unable to run samples and requested service to address the reported event.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay reporting hba1c patient results.There was no indication of any patient intervention or adverse event consequence due to the delay of reporting patient results.
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