Additional information was added to d10, h3, h4, and h6.H10: the device was received for evaluation.Visual inspection was performed which observed that the cap of the burette chamber was missing.The reported condition was verified.The cause of the condition was a manufacturing issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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