H4: the lot was manufactured between june 15, 2023 and june 16, 2023.H10: the actual devices were not available; however, a photograph of the shipping box was provided for evaluation.Visual inspection of the photograph could not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.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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