The device was received for evaluation.A visual inspection with naked eye found one piece of loose, blue particulate matter observed inside the sealed cassette.The disposable device was dry, unused, with caps and tape in place.The reported issue was verified.The cause of the event was determined to be manufacturing related.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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